FDA Orange Book
Generic for Talwin Nx
Talwin Nx contains pentazocine and naloxone. 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 Talwin Nx is pentazocine and naloxone. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Talwin Nx products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 0.5MG BASE;EQ 50MG BASE | Discontinued | None | 3 | AB |
NDA 018733, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pentazocine and naloxone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 074736 | AB (A-rated, therapeutically equivalent) | January 21, 1997 | EQ 0.5MG BASE;EQ 50MG BASE |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 075523 | AB (A-rated, therapeutically equivalent) | March 17, 2000 | EQ 0.5MG BASE;EQ 50MG BASE |
| LUPIN INC | 075735 | AB (A-rated, therapeutically equivalent) | July 11, 2001 | EQ 0.5MG BASE;EQ 50MG BASE |
Questions
Is there a generic for Talwin Nx?
Yes. The generic name for Talwin Nx is pentazocine and naloxone. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Talwin Nx?
The active ingredient in Talwin Nx is pentazocine and naloxone, 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.