FDA Orange Book
Generic for Phenergan
Phenergan contains promethazine. 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 Phenergan is promethazine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Phenergan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 25MG/ML | Discontinued | None | 2 | AP |
| injectable, injection | 50MG/ML | Discontinued | None | 2 | AP |
| suppository, rectal | 12.5MG | Discontinued | None | 3 | AB |
| suppository, rectal | 25MG | Discontinued | None | 3 | AB |
| suppository, rectal | 50MG | Discontinued | None | 1 | None |
| tablet, oral | 12.5MG | Discontinued | None | 5 | AB |
| tablet, oral | 25MG | Discontinued | None | 7 | AB |
| tablet, oral | 50MG | Discontinued | None | 7 | AB |
NDA 008857, 010926, 011689, 007935, held by WYETH AYERST LABORATORIES. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic promethazine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 087165 | None (No TE code listed) | August 14, 1987 | 50MG |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 040428 | AB (A-rated, therapeutically equivalent) | March 31, 2003 | 12.5MG, 25MG |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 040500 | AB (A-rated, therapeutically equivalent) | June 30, 2003 | 12.5MG, 25MG |
| ZYDUS PHARMACEUTICALS USA INC | 040596 | AB (A-rated, therapeutically equivalent) | November 18, 2005 | 12.5MG, 25MG, 50MG |
| PRINSTON PHARMACEUTICAL INC | 040622 | AB (A-rated, therapeutically equivalent) | July 18, 2006 | 12.5MG, 25MG, 50MG |
| KVK TECH INC | 040712 | AB (A-rated, therapeutically equivalent) | May 4, 2007 | 12.5MG, 25MG, 50MG |
| QUAGEN PHARMACEUTICALS LLC | 040673 | AB (A-rated, therapeutically equivalent) | March 5, 2008 | 12.5MG, 25MG, 50MG |
| XGEN PHARMACEUTICALS DJB INC | 040737 | AP (A-rated, therapeutically equivalent) | April 24, 2008 | 25MG/ML, 50MG/ML |
| AMNEAL PHARMACEUTICALS NY LLC | 091179 | AB (A-rated, therapeutically equivalent) | December 13, 2010 | 12.5MG, 25MG, 50MG |
| ANNORA PHARMA PRIVATE LTD | 216446 | AB (A-rated, therapeutically equivalent) | November 2, 2022 | 12.5MG, 25MG |
| HIKMA PHARMACEUTICALS USA INC | 083312 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 25MG/ML, 50MG/ML |
| SANDOZ INC | 084176 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 25MG, 50MG |
| WATSON LABORATORIES INC | 083426 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 25MG |
| WATSON LABORATORIES INC | 083711 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 50MG |
Questions
Is there a generic for Phenergan?
Yes. The generic name for Phenergan is promethazine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Phenergan?
The active ingredient in Phenergan is promethazine, 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.