FDA Orange Book
Generic for Phenergan Vc
Phenergan Vc contains promethazine and phenylephrine. 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 Vc is promethazine and phenylephrine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Phenergan Vc products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| syrup, oral | 5MG/5ML;6.25MG/5ML | Discontinued | None | 2 | AA |
NDA 008604, 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 phenylephrine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC AND DBA PAI PHARMA | 040654 | AA (A-rated, therapeutically equivalent) | December 7, 2006 | 5MG/5ML;6.25MG/5ML |
| AMNEAL PHARMACEUTICALS | 040902 | AA (A-rated, therapeutically equivalent) | August 25, 2009 | 5MG/5ML;6.25MG/5ML |
Questions
Is there a generic for Phenergan Vc?
Yes. The generic name for Phenergan Vc is promethazine and phenylephrine. 2 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 Vc?
The active ingredient in Phenergan Vc is promethazine and phenylephrine, 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.