FDA Orange Book
Generic for Fioricet W/ Codeine
Fioricet W/ Codeine contains butalbital, acetaminophen, 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 Fioricet W/ Codeine is butalbital, acetaminophen, 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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Fioricet 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 | Marketed (Rx) | AB | 2 | AB |
NDA 020232, held by ACTAVIS LABORATORIES UT INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic butalbital, acetaminophen, caffeine and codeine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LGM PHARMA SOLUTIONS LLC | 076560 | AB (A-rated, therapeutically equivalent) | June 10, 2004 | 325MG;50MG;40MG;30MG |
| HIKMA PHARMACEUTICALS USA INC | 215138 | AB (A-rated, therapeutically equivalent) | January 26, 2022 | 325MG;50MG;40MG;30MG |
Fioricet W/ Codeine NDC codes
Questions
Is there a generic for Fioricet W/ Codeine?
Yes. The generic name for Fioricet W/ Codeine is butalbital, acetaminophen, 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 Fioricet W/ Codeine?
The active ingredient in Fioricet W/ Codeine is butalbital, acetaminophen, 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.