Is there a generic for Mepivacaine hydrochloride?

Yes. The FDA Orange Book lists 14 approved generic (ANDA) applications for Mepivacaine hydrochloride, referencing the brand CARBOCAINE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Mepivacaine hydrochloride?

CARBOCAINE (NDA 012125, EASTMAN KODAK) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What dosage forms of Mepivacaine hydrochloride are approved?

Mepivacaine hydrochloride is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Mepivacaine hydrochloride

Mepivacaine hydrochloride: 2 brands, 14 generics; first approved Apr 18, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 14 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

CARBOCAINERLD
EASTMAN KODAKNDA 012125—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3% INJECTABLE INJECTION Discontinued —
CARBOCAINERLD
HOSPIRANDA 012250—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 —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3%	INJECTABLE	INJECTION	Discontinued	—

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	—

Generic (ANDA) products (14)

Abbreviated applications

MEPIVACAINE HYDROCHLORIDE
HOSPIRA INCANDA 0408062008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3% INJECTABLE INJECTION Discontinued —
POLOCAINERS
FRESENIUS KABI USAANDA 0894071986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx —
POLOCAINERS
FRESENIUS KABI USAANDA 0894101986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Rx —
POLOCAINE-MPFRS
FRESENIUS KABI USAANDA 0894061986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx —
POLOCAINE-MPFRS
FRESENIUS KABI USAANDA 0894081986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5% INJECTABLE INJECTION Rx —
POLOCAINE-MPFRS
FRESENIUS KABI USAANDA 0894091986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Rx —
MEPIVACAINE HYDROCHLORIDE
WATSON LABSANDA 0887691984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued —
MEPIVACAINE HYDROCHLORIDE
WATSON LABSANDA 0887701984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued —
SCANDONEST PLAINRS
DEPROCOANDA 0883871984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3% INJECTABLE INJECTION Rx —
POLOCAINE
DENTSPLY PHARMANDA 0886531984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3% INJECTABLE INJECTION Discontinued —
MEPIVACAINE HYDROCHLORIDE
INTL MEDICATION SYSANDA 0875091982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued —
ARESTOCAINE HYDROCHLORIDE
SOLVAYANDA 0847771982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3% INJECTABLE INJECTION Discontinued —
ISOCAINE HYDROCHLORIDE
SEPTODONTANDA 080925—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3% INJECTABLE INJECTION Discontinued —
MEPIVACAINE HYDROCHLORIDE
BELMORA LLCANDA 083559—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3% INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3%	INJECTABLE	INJECTION	Discontinued	—

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

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

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5%	INJECTABLE	INJECTION	Rx	—

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

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

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
3%	INJECTABLE	INJECTION	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3%	INJECTABLE	INJECTION	Discontinued	—

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3%	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3%	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3%	INJECTABLE	INJECTION	Discontinued	—

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Approval history

FDA approval span

First approval

Apr 18, 1982

45 yr 2 mo ago

Most recent approval

Apr 28, 2008

18 yr 9 mo ago

Approvals span 1982–2008 across 16 FDA applications.

Brand (NDA) 213%

Generic (ANDA) 1488%

Mepivacaine 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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