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)
2
Generics (ANDA)
42
Listed patents
0
Presentations
72
Brand (NDA) products
Originator applications
- 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 - DEMEROLRLDQUAGENNDA 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
- MEPERIDINE HYDROCHLORIDEGENUSANDA 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 HYDROCHLORIDESUN 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 HYDROCHLORIDESPECGX LLCANDA 04035220002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - MEPERIDINE HYDROCHLORIDEDURAMED 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 HYDROCHLORIDERSEPIC 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 — - HOSPIRAANDA 0403051999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDESTRIDES 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 HYDROCHLORIDEWATSON LABSANDA 04018619972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - SPECGX LLCANDA 0401631997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEHIKMAANDA 04011019972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - INTL MEDICATIONANDA 0813091993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - WEST-WARD PHARMS INTANDA 0810021993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx — - MEPERIDINE HYDROCHLORIDEWATSON LABSANDA 0734441992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEWATSON LABSANDA 0734451992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - WATSON LABSANDA 0734431992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEIGI LABS INCANDA 0897811989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEIGI LABS INCANDA 0897821989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEIGI LABS INCANDA 0897831989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEIGI LABS INCANDA 0897841989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEIGI LABS INCANDA 0897851989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEIGI LABS INCANDA 0897861989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEIGI LABS INCANDA 0897871989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEIGI LABS INCANDA 0897881989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDERSHIKMAANDA 0887441985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML SYRUP ORAL Rx — - MEPERIDINE HYDROCHLORIDEBARRANDA 0886401984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - ICU MEDICAL INCANDA 0884321984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEBARRANDA 0886391984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - MEPERIDINE HYDROCHLORIDEBAXTER HLTHCAREANDA 0882791984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEBAXTER HLTHCAREANDA 0882801984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEBAXTER HLTHCAREANDA 0882811984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEBAXTER HLTHCAREANDA 0882821984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEABBOTTANDA 080388—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEABBOTTANDA 080385—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEABBOTTANDA 080387—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEABBOTTANDA 080389—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEABBOTTANDA 080386—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEINTL MEDICATIONANDA 086332—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - MEPERIDINE HYDROCHLORIDEPARKE 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 HYDROCHLORIDEWEST-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 HYDROCHLORIDEWEST-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 HYDROCHLORIDESUN 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 HYDROCHLORIDEWYETH AYERSTANDA 080454—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL 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
42 yr 11 mo ago
Most recent approval
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.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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