Is there a generic for Lidocaine hydrochloride?

Yes. The FDA Orange Book lists 94 approved generic (ANDA) applications for Lidocaine hydrochloride, referencing the brand AKTEN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Lidocaine hydrochloride?

AKTEN (NDA 022221, THEA PHARMA) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Lidocaine hydrochloride?

The Orange Book lists 4 patents against Lidocaine hydrochloride products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Lidocaine hydrochloride are approved?

Lidocaine hydrochloride is approved in the following dosage forms: gel, injectable, jelly, solution, system.

FDA Orange Book · active-ingredient family

Lidocaine hydrochloride

Lidocaine hydrochloride: 22 brands, 94 generics; first approved Feb 02, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 94 ANDA applications approved.

Earliest patent expiry Jul 24, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jul 24, 2026

3 mo ago

Brand (NDA) products

Originator applications

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AKTENRLDRS
THEA PHARMANDA 0222212008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3.5% GEL OPHTHALMIC Rx -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3.5%	GEL	OPHTHALMIC	Rx	-

XYLOCAINE PRESERVATIVE FREERLD

FRESENIUS KABI USANDA 01680119885 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	INJECTABLE	INJECTION	Discontinued	-
4%	INJECTABLE	INJECTION	Discontinued	-
10%	INJECTABLE	INJECTION	Discontinued	-
20%	INJECTABLE	INJECTION	Discontinued	-
1%	INJECTABLE	INJECTION	Discontinued	-

XYLOCAINERLDRS
FRESENIUS KABI USANDA 006488-4 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Rx AP
1% INJECTABLE INJECTION Rx AP
0.5% INJECTABLE INJECTION Rx AP
1.5% INJECTABLE INJECTION Rx AP
XYLOCAINE 4% PRESERVATIVE FREERLD
FRESENIUS KABI USANDA 010417-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% INJECTABLE INJECTION Discontinued -
4% SOLUTION TOPICAL Discontinued -
XYLOCAINERLD
EPIC PHARMA LLCNDA 008816-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% JELLY TOPICAL Discontinued -
XYLOCAINE VISCOUSRLD
FRESENIUS KABI USANDA 009470-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Discontinued -
ZINGO
POWDER PHARMSNDA 0221142007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG SYSTEM INTRADERMAL Discontinued -
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUNNDA 01983019923 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG/100ML INJECTABLE INJECTION Rx AP
400MG/100ML INJECTABLE INJECTION Rx AP
800MG/100ML INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBOTTNDA 0189541985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG/100ML INJECTABLE INJECTION Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	INJECTABLE	INJECTION	Rx	AP
1%	INJECTABLE	INJECTION	Rx	AP
0.5%	INJECTABLE	INJECTION	Rx	AP
1.5%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	INJECTABLE	INJECTION	Discontinued	-
4%	SOLUTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	JELLY	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	SYSTEM	INTRADERMAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/100ML	INJECTABLE	INJECTION	Rx	AP
400MG/100ML	INJECTABLE	INJECTION	Rx	AP
800MG/100ML	INJECTABLE	INJECTION	Rx	AP

LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUNNDA 01896719843 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/100ML	INJECTABLE	INJECTION	Discontinued	-
400MG/100ML	INJECTABLE	INJECTION	Discontinued	-
800MG/100ML	INJECTABLE	INJECTION	Discontinued	-

XYLOCAINE 5% W/ GLUCOSE 7.5%
ASTRAZENECANDA 0104961982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% INJECTABLE SPINAL Discontinued -
LIDOCAINE HYDROCHLORIDE
ABRAXIS PHARMNDA 017508-3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued -
4% INJECTABLE INJECTION Discontinued -
20% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
INTL MEDICATIONNDA 017701-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued -
1% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
INTL MEDICATIONNDA 018543-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1GM/VIAL INJECTABLE INJECTION Discontinued -
2GM/VIAL INJECTABLE INJECTION Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	INJECTABLE	SPINAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM/VIAL	INJECTABLE	INJECTION	Discontinued	-
2GM/VIAL	INJECTABLE	INJECTION	Discontinued	-

LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARENDA 018461-4 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/100ML	INJECTABLE	INJECTION	Discontinued	-
200MG/100ML	INJECTABLE	INJECTION	Rx	AP
400MG/100ML	INJECTABLE	INJECTION	Rx	AP
800MG/100ML	INJECTABLE	INJECTION	Rx	AP

LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER

HOSPIRANDA 018388-3 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/100ML	INJECTABLE	INJECTION	Discontinued	-
400MG/100ML	INJECTABLE	INJECTION	Discontinued	-
800MG/100ML	INJECTABLE	INJECTION	Discontinued	-

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
FRESENIUS KABI USANDA 017584-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Rx AP
4% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
INTL MEDICATIONNDA 017702-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20% INJECTABLE INJECTION Discontinued -
4% INJECTABLE INJECTION Discontinued -
LIDOPEN
MERIDIAN MEDCL TECHNNDA 017549-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10% INJECTABLE INJECTION Discontinued -
XYLOCAINE
ASTRAZENECANDA 010418-3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued -
2% INJECTABLE INJECTION Discontinued -
1.5% INJECTABLE INJECTION Discontinued -
XYLOCAINE DENTAL
DENTSPLY PHARMNDA 021380-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued -
XYLOCAINE 1.5% W/ DEXTROSE 7.5%
FRESENIUS KABI USANDA 016297-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5% INJECTABLE SPINAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	INJECTABLE	INJECTION	Rx	AP
4%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20%	INJECTABLE	INJECTION	Discontinued	-
4%	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10%	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5%	INJECTABLE	SPINAL	Discontinued	-

Generic (ANDA) products (94)

Abbreviated applications

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LIDOCAINE HYDROCHLORIDE
QUAGENANDA 2186762026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Rx AT
LIDOCAINE HYDROCHLORIDE
VIWIT PHARMANDA 22007120262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
AUROBINDO PHARMA LTDANDA 2197592025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Rx AT
LIDOCAINE HYDROCHLORIDE
ANTHEA PHARMAANDA 21953520252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
THE J MOLNERANDA 2184112024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE VISCOUS
PAI HOLDINGS PHARMANDA 2181382024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Rx AT
LIDOCAINE HYDROCHLORIDE
SUN PHARMA CANADAANDA 2181822023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE
MANKIND PHARMAANDA 21769320232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
MANKIND PHARMAANDA 21769220233 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
1% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDERS
RUBICON RESEARCHANDA 2167802023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Rx AT
LIDOCAINE HYDROCHLORIDE
YILINGANDA 21426720222 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
AFAXYSANDA 2151322022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
YILINGANDA 2142692022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
NOVITIUM PHARMAANDA 2162502022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE
ASPIROANDA 21433620212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
ASPIROANDA 21433920212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
HUONSANDA 21282120202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
B BRAUN MEDICALANDA 2084742018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
SPECTRA MDCL DEVICESANDA 2080172018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
EUGIA PHARMAANDA 20718220172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
AM REGENTANDA 0915642015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued -
GLYDORS
SAGENT PHARMS INCANDA 2010942014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% JELLY TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE
RISINGANDA 2022422014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
PAI HOLDINGS PHARMANDA 2044942014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
EUGIA PHARMAANDA 20304020132 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued -
2% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
EUGIA PHARMAANDA 20308220132 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
WATSON LABS INCANDA 0408372011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% JELLY TOPICAL Discontinued -
LIDOCAINE HYDROCHLORIDE
RISINGANDA 09105620102 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% INJECTABLE INJECTION Discontinued -
1% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
RISINGANDA 09105820102 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% INJECTABLE INJECTION Discontinued -
1% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
CHARTWELL RXANDA 0906652010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE VISCOUS
CHARTWELL MOLECULARANDA 0407082007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Rx AT
LIDOCAINE HYDROCHLORIDE
LANNETT CO INCANDA 0407102007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE
SENTISSANDA 0404332003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% JELLY TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER
HOSPIRAANDA 04030219982 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
HIKMAANDA 0400141995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Discontinued -
LIDOCAINE HYDROCHLORIDE
HOSPIRAANDA 0400131995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
HOSPIRAANDA 0400781995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
COSETTE PHARMS NCANDA 0813181993
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% JELLY TOPICAL Discontinued -
LIDOCAINE HYDROCHLORIDE
PACOANDA 0896881989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Discontinued -
LIDOCAINE HYDROCHLORIDE
ABBOTTANDA 0893621988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20% INJECTABLE INJECTION Discontinued -
LIDOCAINE VISCOUS
HIKMAANDA 0888021985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Rx AT
LIDOCAINE HYDROCHLORIDERS
HIKMAANDA 0888031985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
HOSPIRAANDA 0883251984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
HOSPIRAANDA 0882991984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
HOSPIRAANDA 0883261984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
HOSPIRAANDA 0883271984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
HOSPIRAANDA 0883671984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
HOSPIRAANDA 0883681984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20% INJECTABLE INJECTION Discontinued -
LTA II KIT
HOSPIRAANDA 0885421984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Discontinued -
PEDIATRIC LTA KIT
ABBOTTANDA 0885721984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL Discontinued -
LIDOCAINE HYDROCHLORIDE
HOSPIRAANDA 0883281984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
HOSPIRAANDA 0883291984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
HOSPIRAANDA 0883301984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
HOSPIRAANDA 0882941984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
HOSPIRAANDA 0883311984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREERS
HOSPIRAANDA 0882951984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% INJECTABLE INJECTION Rx AP
LIDOCATON
PHARMATONANDA 0847271983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued -
LARYNGOTRACHEAL ANESTHESIA KIT
KENDALL ILANDA 0879311983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Discontinued -
LIDOCAINE HYDROCHLORIDE
ABBOTTANDA 0879801983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
PHARMOBEDIENTANDA 0878721982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Rx AT
LIDOCAINE HYDROCHLORIDE
PHARMOBEDIENTANDA 0878811982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE VISCOUS
INTL MEDICATIONANDA 0863891982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Discontinued -
ALPHACAINE HYDROCHLORIDE
CARLISLEANDA 084721-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	ORAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	ORAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	ORAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP
1%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	ORAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	JELLY	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	JELLY	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	INJECTABLE	INJECTION	Discontinued	-
1%	INJECTABLE	INJECTION	Discontinued	-

LIDOCAINE HYDROCHLORIDE

ABRAXIS PHARMANDA 080420-4 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Discontinued	-
2%	INJECTABLE	INJECTION	Discontinued	-
2%	INJECTABLE	INJECTION	Discontinued	-
1.5%	INJECTABLE	INJECTION	Discontinued	-

LIDOCAINE HYDROCHLORIDE
ABRAXIS PHARMANDA 086761-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued -
2% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
AM REGENTANDA 080850-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
BEL MARANDA 080710-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
BEL MARANDA 080760-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
BELMORA LLCANDA 080504-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
DELL LABSANDA 083387-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
DELL LABSANDA 083388-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
ELKINS SINNANDA 085131-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
ELKINS SINNANDA 084626-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
EPIC PHARMA LLCANDA 085037-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued -
2% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
FRESENIUS KABI USAANDA 088586-3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
GD SEARLE LLCANDA 083135-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued -
2% INJECTABLE INJECTION Discontinued -

LIDOCAINE HYDROCHLORIDERLD

HOSPIRAANDA 083158-5 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Discontinued	-
2%	INJECTABLE	INJECTION	Discontinued	-
20%	INJECTABLE	INJECTION	Discontinued	-
200MG/100ML	INJECTABLE	INJECTION	Discontinued	-
400MG/100ML	INJECTABLE	INJECTION	Discontinued	-

LIDOCAINE HYDROCHLORIDERLD
INTL MEDICATIONANDA 083173-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
LUITPOLDANDA 083198-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
LYPHOMEDANDA 080390-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued -
2% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
MILESANDA 080414-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued -
2% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
WATSON LABSANDA 080377-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued -
2% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
WATSON LABSANDA 083627-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued -
2% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE
WEST-WARD PHARMS INTANDA 080407-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
WYETH AYERSTANDA 083083-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued -
2% INJECTABLE INJECTION Discontinued -
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
HIKMAANDA 084625-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
HOSPIRAANDA 080408-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
1.5% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%RLDRS
HOSPIRAANDA 083914-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% INJECTABLE SPINAL Rx -
ANESTACON
BIONPHARMAANDA 080429-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% JELLY TOPICAL Discontinued -
LIDOCAINE HYDROCHLORIDE
INTL MEDICATIONANDA 086283-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% JELLY TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE VISCOUS
ACTAVIS MID ATLANTICANDA 086578-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Discontinued -
LARYNG-O-JET KIT
INTL MEDICATIONANDA 086364-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Rx AT
LTA II KIT
HOSPIRAANDA 080409-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Discontinued -
PEDIATRIC LTA KIT
HOSPIRAANDA 085995-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL Discontinued -

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8759401	Jul 24, 2026	3 mo ago	ProductU-1523
8540665	Oct 22, 2029	in 3 yr	U-1438
9358338	Apr 27, 2035	in 8 yr 8 mo	U-1870
9370622	Sep 28, 2035	in 9 yr 1 mo	U-1870

Approval history

FDA approval span

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First approval

Feb 02, 1982

45 yr 5 mo ago

Most recent approval

Mar 20, 2026

7 mo ago

Approvals span 1982–2026 across 116 FDA applications.

Brand (NDA) 2219%

Generic (ANDA) 9481%

Lidocaine hydrochloride: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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Key facts