FDA Orange Book
Generic for Nubain
Nubain contains nalbuphine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Nubain is nalbuphine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 4 of the 5 Nubain products the Orange Book lists.
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Nubain products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intramuscular, intravenous, subcutaneous | 100MG/10ML (10MG/ML) | Discontinued | None | 2 | AP |
| solution, intramuscular, intravenous, subcutaneous | 10MG/ML (10MG/ML) | Discontinued | None | 2 | AP |
| solution, intramuscular, intravenous, subcutaneous | 200MG/10ML (20MG/ML) | Discontinued | None | 2 | AP |
| solution, intramuscular, intravenous, subcutaneous | 20MG/2ML (10MG/ML) | Discontinued | None | 0 | None |
| solution, intramuscular, intravenous, subcutaneous | 20MG/ML (20MG/ML) | Discontinued | None | 2 | AP |
NDA 018024, held by PH HEALTH LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nalbuphine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HOSPIRA INC | 070915 | AP (A-rated, therapeutically equivalent) | February 3, 1989 | 100MG/10ML (10MG/ML) |
| HOSPIRA INC | 070914 | AP (A-rated, therapeutically equivalent) | February 3, 1989 | 10MG/ML (10MG/ML) |
| HOSPIRA INC | 070918 | AP (A-rated, therapeutically equivalent) | February 3, 1989 | 200MG/10ML (20MG/ML) |
| HOSPIRA INC | 070916 | AP (A-rated, therapeutically equivalent) | February 3, 1989 | 20MG/ML (20MG/ML) |
| SOMERSET THERAPEUTICS LLC | 216049 | AP (A-rated, therapeutically equivalent) | September 19, 2024 | 100MG/10ML (10MG/ML), 200MG/10ML (20MG/ML) |
| SOMERSET THERAPEUTICS LLC | 216050 | AP (A-rated, therapeutically equivalent) | September 19, 2024 | 10MG/ML (10MG/ML), 20MG/ML (20MG/ML) |
Questions
Is there a generic for Nubain?
Yes. The generic name for Nubain is nalbuphine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 4 of the 5 Nubain products the Orange Book lists.
What is the generic name for Nubain?
The active ingredient in Nubain is nalbuphine, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.