FDA Orange Book
Generic for Fiorinal W/codeine
Fiorinal W/codeine contains butalbital, aspirin, caffeine 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 Fiorinal W/codeine is butalbital, aspirin, caffeine and codeine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Fiorinal W/codeine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 325MG;50MG;40MG;30MG | Discontinued | None | 2 | AB |
NDA 019429, held by ALLERGAN SALES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic butalbital, aspirin, caffeine and codeine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| JEROME STEVENS PHARMACEUTICALS INC | 074951 | AB (A-rated, therapeutically equivalent) | August 31, 1998 | 325MG;50MG;40MG;30MG |
| LGM PHARMA SOLUTIONS LLC | 075231 | AB (A-rated, therapeutically equivalent) | November 30, 2001 | 325MG;50MG;40MG;30MG |
Questions
Is there a generic for Fiorinal W/codeine?
Yes. The generic name for Fiorinal W/codeine is butalbital, aspirin, caffeine and codeine. 2 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 Fiorinal W/codeine?
The active ingredient in Fiorinal W/codeine is butalbital, aspirin, caffeine 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.