Acetaminophen; butalbital; caffeine; codeine phosphate
Acetaminophen; butalbital; caffeine; codeine phosphate: 1 brand, 7 generics; first approved Jul 30, 1992; generic available.
Generic available: 7 ANDA applications approved.
Brand (NDA) products
- ACTAVIS LABS UT INCNDA 0202321992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 325MG;50MG;40MG;30MG CAPSULE ORAL Rx AB
Generic (ANDA) products (7)
- HIKMAANDA 21513820222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 325MG;50MG;40MG;30MG CAPSULE ORAL Rx AB 300MG;50MG;40MG;30MG CAPSULE ORAL Rx AB - QUAGENANDA 2046492020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 325MG;50MG;40MG;30MG CAPSULE ORAL Discontinued - - LGM PHARMAANDA 07656020122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 325MG;50MG;40MG;30MG CAPSULE ORAL Rx AB 300MG;50MG;40MG;30MG CAPSULE ORAL Rx AB - ABLEANDA 0765282003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 325MG;50MG;40MG;30MG CAPSULE ORAL Discontinued - - PHARMOBEDIENTANDA 0759292002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 325MG;50MG;40MG;30MG CAPSULE ORAL Discontinued - - VALEANTANDA 0749112001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 325MG;50MG;40MG;30MG CAPSULE ORAL Discontinued - - HIKMA INTL PHARMSANDA 0756182001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 325MG;50MG;40MG;30MG CAPSULE ORAL Discontinued -
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 1992–2022 across 8 FDA applications.
Acetaminophen; butalbital; caffeine; codeine phosphate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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