Is there a generic for Meperidine hydrochloride?

Yes. The FDA Orange Book lists 42 approved generic (ANDA) applications for Meperidine hydrochloride, referencing the brand DEMEROL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Meperidine hydrochloride?

DEMEROL (NDA 021171, HOSPIRA) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What dosage forms of Meperidine hydrochloride are approved?

Meperidine hydrochloride is approved in the following dosage forms: injectable, syrup, tablet.

FDA Orange Book · active-ingredient family

Meperidine hydrochloride

Meperidine hydrochloride: 2 brands, 42 generics; first approved Jun 15, 1984; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 42 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

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DEMEROLRLDRS
HOSPIRANDA 021171-4 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG/ML INJECTABLE INJECTION Rx AP
50MG/ML INJECTABLE INJECTION Rx AP
75MG/ML INJECTABLE INJECTION Rx AP
100MG/ML INJECTABLE INJECTION Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Rx	AP
50MG/ML	INJECTABLE	INJECTION	Rx	AP
75MG/ML	INJECTABLE	INJECTION	Rx	AP
100MG/ML	INJECTABLE	INJECTION	Rx	AP

DEMEROLRLD

QUAGENNDA 005010-7 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	-
50MG/ML	INJECTABLE	INJECTION	Discontinued	-
100MG/ML	INJECTABLE	INJECTION	Discontinued	-
100MG	TABLET	ORAL	Discontinued	-
50MG/5ML	SYRUP	ORAL	Discontinued	-
25MG/ML	INJECTABLE	INJECTION	Discontinued	-
75MG/ML	INJECTABLE	INJECTION	Discontinued	-

Generic (ANDA) products (42)

Abbreviated applications

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MEPERIDINE HYDROCHLORIDE
GENUSANDA 04089320094 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Rx AA
75MG TABLET ORAL Discontinued -
100MG TABLET ORAL Discontinued -
150MG TABLET ORAL Discontinued -
MEPERIDINE HYDROCHLORIDE
SUN PHARM INDS INCANDA 04044620022 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
100MG TABLET ORAL Discontinued -
MEPERIDINE HYDROCHLORIDE
SPECGX LLCANDA 04035220002 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
100MG TABLET ORAL Discontinued -
MEPERIDINE HYDROCHLORIDE
DURAMED PHARMS BARRANDA 04031819992 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
100MG TABLET ORAL Discontinued -
MEPERIDINE HYDROCHLORIDERS
EPIC PHARMA LLCANDA 04033119992 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Rx AA
100MG TABLET ORAL Rx -
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
HOSPIRAANDA 0403051999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
STRIDES PHARMA INTLANDA 04019119982 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
100MG TABLET ORAL Discontinued -
MEPERIDINE HYDROCHLORIDE
WATSON LABSANDA 04018619972 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
100MG TABLET ORAL Discontinued -
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
SPECGX LLCANDA 0401631997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
HIKMAANDA 04011019972 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
100MG TABLET ORAL Discontinued -
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
INTL MEDICATIONANDA 0813091993
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREERS
WEST-WARD PHARMS INTANDA 0810021993
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Rx -
MEPERIDINE HYDROCHLORIDE
WATSON LABSANDA 0734441992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
WATSON LABSANDA 0734451992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
WATSON LABSANDA 0734431992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
IGI LABS INCANDA 0897811989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
IGI LABS INCANDA 0897821989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
IGI LABS INCANDA 0897831989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
IGI LABS INCANDA 0897841989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
IGI LABS INCANDA 0897851989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
75MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
IGI LABS INCANDA 0897861989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
IGI LABS INCANDA 0897871989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
IGI LABS INCANDA 0897881989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDERS
HIKMAANDA 0887441985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/5ML SYRUP ORAL Rx -
MEPERIDINE HYDROCHLORIDE
BARRANDA 0886401984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET ORAL Discontinued -
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREERLD
ICU MEDICAL INCANDA 0884321984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
BARRANDA 0886391984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
MEPERIDINE HYDROCHLORIDE
BAXTER HLTHCAREANDA 0882791984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
BAXTER HLTHCAREANDA 0882801984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
BAXTER HLTHCAREANDA 0882811984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
75MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
BAXTER HLTHCAREANDA 0882821984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
ABBOTTANDA 080388-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
ABBOTTANDA 080385-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
ABBOTTANDA 080387-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
ABBOTTANDA 080389-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
75MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
ABBOTTANDA 080386-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
INTL MEDICATIONANDA 086332-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
PARKE DAVISANDA 080364-3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/ML INJECTABLE INJECTION Discontinued -
50MG/ML INJECTABLE INJECTION Discontinued -
75MG/ML INJECTABLE INJECTION Discontinued -
MEPERIDINE HYDROCHLORIDE
WEST-WARD PHARMS INTANDA 080445-4 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG/ML INJECTABLE INJECTION Rx AP
50MG/ML INJECTABLE INJECTION Rx AP
75MG/ML INJECTABLE INJECTION Rx AP
100MG/ML INJECTABLE INJECTION Rx AP
MEPERIDINE HYDROCHLORIDE
WEST-WARD PHARMS INTANDA 080455-4 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG/ML INJECTABLE INJECTION Rx AP
50MG/ML INJECTABLE INJECTION Rx AP
75MG/ML INJECTABLE INJECTION Rx AP
100MG/ML INJECTABLE INJECTION Rx AP
MEPERIDINE HYDROCHLORIDE
SUN PHARM INDUSTRIESANDA 080448-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
100MG TABLET ORAL Discontinued -
MEPERIDINE HYDROCHLORIDE
WYETH AYERSTANDA 080454-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Rx	AA
75MG	TABLET	ORAL	Discontinued	-
100MG	TABLET	ORAL	Discontinued	-
150MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Rx	AA
100MG	TABLET	ORAL	Rx	-

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

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

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	-

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

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
75MG/ML	INJECTABLE	INJECTION	Discontinued	-

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

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

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/5ML	SYRUP	ORAL	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Discontinued	-

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
75MG/ML	INJECTABLE	INJECTION	Discontinued	-

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
75MG/ML	INJECTABLE	INJECTION	Discontinued	-

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

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/ML	INJECTABLE	INJECTION	Discontinued	-
50MG/ML	INJECTABLE	INJECTION	Discontinued	-
75MG/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Rx	AP
50MG/ML	INJECTABLE	INJECTION	Rx	AP
75MG/ML	INJECTABLE	INJECTION	Rx	AP
100MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Rx	AP
50MG/ML	INJECTABLE	INJECTION	Rx	AP
75MG/ML	INJECTABLE	INJECTION	Rx	AP
100MG/ML	INJECTABLE	INJECTION	Rx	AP

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

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First approval

Jun 15, 1984

43 yr ago

Most recent approval

Jun 24, 2009

17 yr 7 mo ago

Approvals span 1984–2009 across 44 FDA applications.

Brand (NDA) 25%

Generic (ANDA) 4295%

Meperidine 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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