FDA Orange Book · active-ingredient family
Nalbuphine hydrochloride
Nalbuphine hydrochloride: 2 brands, 18 generics; first approved May 27, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 18 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
18
Listed patents
0
Presentations
33
Brand (NDA) products
Originator applications
- NUBAINRLDPH HEALTHNDA 018024-5 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML (10MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - 20MG/ML (20MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - 100MG/10ML (10MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - 20MG/2ML (10MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - 200MG/10ML (20MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - - NALBUPHINE HYDROCHLORIDEABBVIENDA 0202001993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG/ML INJECTABLE INJECTION Discontinued -
Generic (ANDA) products (18)
Abbreviated applications
- NALBUPHINE HYDROCHLORIDESOMERSET THERAPS LLCANDA 21605020242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML (10MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP 20MG/ML (20MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP - NALBUPHINE HYDROCHLORIDESOMERSET THERAPS LLCANDA 21604920242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/10ML (10MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP 200MG/10ML (20MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP - NALBUPHINE HYDROCHLORIDERISINGANDA 20650620192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/10ML (10MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - 200MG/10ML (20MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - - NALBUPHINE HYDROCHLORIDERISINGANDA 20759520192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML (10MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - 20MG/ML (20MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - - NALBUPHINE HYDROCHLORIDEDR REDDYSANDA 07447119982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/10ML (10MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - 200MG/10ML (20MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - - NALBUPHINE HYDROCHLORIDEIGI LABS INCANDA 07207019892 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML (10MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - 100MG/10ML (10MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - - NALBUPHINE HYDROCHLORIDEIGI LABS INCANDA 0720711989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML (10MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - - NALBUPHINE HYDROCHLORIDEIGI LABS INCANDA 0720721989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML (10MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - - NALBUPHINE HYDROCHLORIDEIGI LABS INCANDA 07207319892 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML (20MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - 200MG/10ML (20MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - - NALBUPHINE HYDROCHLORIDEIGI LABS INCANDA 0720741989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML (20MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - - NALBUPHINE HYDROCHLORIDEIGI LABS INCANDA 0720751989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML (20MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - - NALBUPHINE HYDROCHLORIDEABBOTTANDA 0709171989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML (20MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - - NALBUPHINE HYDROCHLORIDERSHOSPIRAANDA 0709141989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML (10MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP - NALBUPHINE HYDROCHLORIDERSHOSPIRAANDA 0709161989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML (20MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP - NALBUPHINE HYDROCHLORIDERSHOSPIRAANDA 0709151989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/10ML (10MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP - NALBUPHINE HYDROCHLORIDERSHOSPIRAANDA 0709181989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/10ML (20MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP - ABRAXIS PHARMANDA 07075219862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML (20MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - 200MG/10ML (20MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - - ABRAXIS PHARMANDA 07075119862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML (10MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued - 100MG/10ML (10MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 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
45 yr 1 mo ago
Most recent approval
2 yr 2 mo ago
Approvals span 1982–2024 across 20 FDA applications.
Brand (NDA) 210%
Generic (ANDA) 1890%
Nalbuphine 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
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
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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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