FDA Orange Book
Generic for Phenergan W/ Codeine
Phenergan W/ Codeine contains promethazine and codeine. 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 W/ Codeine is promethazine and codeine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Phenergan W/ Codeine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| syrup, oral | 10MG/5ML;6.25MG/5ML | Discontinued | None | 5 | AA |
NDA 008306, held by ANI PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic promethazine and codeine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PHARMOBEDIENT CONSULTING LLC | 088875 | AA (A-rated, therapeutically equivalent) | December 17, 1984 | 10MG/5ML;6.25MG/5ML |
| CHARTWELL RX SCIENCES LLC | 090180 | AA (A-rated, therapeutically equivalent) | March 17, 2010 | 10MG/5ML;6.25MG/5ML |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 200386 | AA (A-rated, therapeutically equivalent) | June 29, 2012 | 10MG/5ML;6.25MG/5ML |
| AMNEAL PHARMACEUTICALS | 200894 | AA (A-rated, therapeutically equivalent) | April 24, 2013 | 10MG/5ML;6.25MG/5ML |
| QUAGEN PHARMACEUTICALS LLC | 214238 | AA (A-rated, therapeutically equivalent) | October 8, 2020 | 10MG/5ML;6.25MG/5ML |
Questions
Is there a generic for Phenergan W/ Codeine?
Yes. The generic name for Phenergan W/ Codeine is promethazine and codeine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Phenergan W/ Codeine?
The active ingredient in Phenergan W/ Codeine is promethazine and codeine, 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.