Is there a generic for Aspirin; butalbital; caffeine?

Yes. The FDA Orange Book lists 14 approved generic (ANDA) applications for Aspirin; butalbital; caffeine, referencing the brand FIORINAL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Aspirin; butalbital; caffeine?

FIORINAL (NDA 017534, ALLERGAN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Aspirin; butalbital; caffeine are approved?

Aspirin; butalbital; caffeine is approved in the following dosage forms: capsule, tablet.

FDA Orange Book · active-ingredient family

Aspirin; butalbital; caffeine

Aspirin; butalbital; caffeine: 1 brand, 14 generics; first approved Aug 23, 1983; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 14 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

FIORINALRLD

ALLERGANNDA 01753419862 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (14)

BUTALBITAL, ASPIRIN AND CAFFEINE

LGM PHARMAANDA 2052302021

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG;50MG;40MG	CAPSULE	ORAL	Discontinued	—

BUTALBITAL, ASPIRIN AND CAFFEINE

STRIDES PHARMAANDA 2041952016

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;50MG;40MG	TABLET	ORAL	Discontinued	—

BUTALBITAL, ASPIRIN AND CAFFEINE

MPP PHARMAANDA 0781492007

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;50MG;40MG	CAPSULE	ORAL	Rx	AA

BUTALBITAL, ASPIRIN AND CAFFEINE

HALSEYANDA 0894481986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;50MG;40MG	TABLET	ORAL	Discontinued	—

LANORINAL

LANNETTANDA 0869861985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;50MG;40MG	TABLET	ORAL	Discontinued	—

LANORINALRS

SANDOZANDA 0869961985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;50MG;40MG	CAPSULE	ORAL	Rx	AA

BUTALBITAL, ASPIRIN AND CAFFEINE

QUANTUM PHARMICSANDA 0889721985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;50MG;40MG	TABLET	ORAL	Discontinued	—

BUTALBITAL, ASPIRIN AND CAFFEINE

WATSON LABSANDA 0862311985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;50MG;40MG	CAPSULE	ORAL	Discontinued	—

BUTALBITAL, ASPIRIN AND CAFFEINE

IVAX PHARMSANDA 0854411984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;50MG;40MG	TABLET	ORAL	Discontinued	—

BUTALBITAL, ASPIRIN AND CAFFEINE

FOSUN PHARMAANDA 0863981984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;50MG;40MG	TABLET	ORAL	Discontinued	—

BUTALBITAL, ASPIRIN AND CAFFEINE

WATSON LABSANDA 0862371984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;50MG;40MG	TABLET	ORAL	Discontinued	—

BUTALBITAL, ASPIRIN AND CAFFEINERLD

HIKMA INTL PHARMSANDA 0861621984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—

BUTALBITAL, ASPIRIN AND CAFFEINE

PURACAP PHARMANDA 0870481983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;50MG;40MG	TABLET	ORAL	Discontinued	—

BUTALBITAL, ASPIRIN AND CAFFEINE

ACTAVIS ELIZABETHANDA 0867101983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;50MG;40MG	TABLET	ORAL	Discontinued	—

Orange Book patent file

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.

FDA approval span

Approval history

First approval

Aug 23, 1983

43 yr 6 mo ago

Most recent approval

Oct 18, 2021

4 yr 10 mo ago

Approvals span 1983–2021 across 15 FDA applications.

Brand (NDA) 17%

Generic (ANDA) 1493%

Aspirin; butalbital; caffeine — 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.

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