FDA Orange Book
Generic for Fiorinal
Fiorinal contains butalbital, aspirin and caffeine. 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 is butalbital, aspirin and caffeine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 1 of the 2 Fiorinal products the Orange Book lists.
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Fiorinal products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 325MG;50MG;40MG | Discontinued | None | 2 | AA |
| tablet, oral | 325MG;50MG;40MG | Discontinued | None | 0 | None |
NDA 017534, 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 and caffeine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 086996 | AA (A-rated, therapeutically equivalent) | October 11, 1985 | 325MG;50MG;40MG |
| MPP PHARMA LLC | 078149 | AA (A-rated, therapeutically equivalent) | June 13, 2007 | 325MG;50MG;40MG |
Questions
Is there a generic for Fiorinal?
Yes. The generic name for Fiorinal is butalbital, aspirin and caffeine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 1 of the 2 Fiorinal products the Orange Book lists.
What is the generic name for Fiorinal?
The active ingredient in Fiorinal is butalbital, aspirin and caffeine, 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.