Is there a generic for Butabarbital sodium?

Yes. The FDA Orange Book lists 31 approved generic (ANDA) applications for Butabarbital sodium, referencing the brand BUTISOL SODIUM. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Butabarbital sodium?

BUTISOL SODIUM (NDA 000793, PHARMOBEDIENT) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Butabarbital sodium are approved?

Butabarbital sodium is approved in the following dosage forms: capsule, elixir, tablet.

FDA Orange Book · active-ingredient family

Butabarbital sodium

Butabarbital sodium: 1 brand, 31 generics; first approved Feb 09, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 31 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

BUTISOL SODIUMRLD

PHARMOBEDIENTNDA 000793—4 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
30MG	TABLET	ORAL	Discontinued	—
100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (31)

BUTABARBITAL SODIUM

TEVAANDA 0886321985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	TABLET	ORAL	Discontinued	—

BUTABARBITAL SODIUM

TEVAANDA 0886311985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG	TABLET	ORAL	Discontinued	—

BUTABARBITAL SODIUM

SANDOZANDA 0842921982

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	TABLET	ORAL	Discontinued	—

BUTICAPS

MEDPOINTE PHARM HLCANDA 085381—4 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Discontinued	—
30MG	CAPSULE	ORAL	Discontinued	—
50MG	CAPSULE	ORAL	Discontinued	—
100MG	CAPSULE	ORAL	Discontinued	—

BUTABARB

ALPHARMA US PHARMSANDA 085873—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG/5ML	ELIXIR	ORAL	Discontinued	—

BUTABARBITAL SODIUM

WOCKHARDTANDA 085383—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG/5ML	ELIXIR	ORAL	Discontinued	—

BUTALAN

LANNETTANDA 085880—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
33.3MG/5ML	ELIXIR	ORAL	Discontinued	—

BUTISOL SODIUM

MEDA PHARMSANDA 085380—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG/5ML	ELIXIR	ORAL	Discontinued	—

SARISOL

HALSEYANDA 084723—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG/5ML	ELIXIR	ORAL	Discontinued	—

BUTABARBITAL

BUNDYANDA 085550—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG	TABLET	ORAL	Discontinued	—

BUTABARBITAL SODIUMRLD

SANDOZANDA 085938—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	TABLET	ORAL	Discontinued	—

BUTABARBITAL SODIUM

SANDOZANDA 084272—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG	TABLET	ORAL	Discontinued	—

BUTABARBITAL SODIUM

SANDOZANDA 085934—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG	TABLET	ORAL	Discontinued	—

BUTABARBITAL SODIUM

SOLVAYANDA 083606—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
16.2MG	TABLET	ORAL	Discontinued	—

BUTABARBITAL SODIUM

SOLVAYANDA 083898—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
32.4MG	TABLET	ORAL	Discontinued	—

BUTABARBITAL SODIUM

SOLVAYANDA 083897—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
48.6MG	TABLET	ORAL	Discontinued	—

BUTABARBITAL SODIUM

SOLVAYANDA 083896—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
97.2MG	TABLET	ORAL	Discontinued	—

BUTABARBITAL SODIUM

WATSON LABSANDA 085764—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	TABLET	ORAL	Discontinued	—

BUTABARBITAL SODIUM

WATSON LABSANDA 085772—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG	TABLET	ORAL	Discontinued	—

BUTABARBITAL SODIUM

WHITEWORTH TOWN PLSNANDA 083325—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	TABLET	ORAL	Discontinued	—

BUTABARBITAL SODIUM

WHITEWORTH TOWN PLSNANDA 083337—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG	TABLET	ORAL	Discontinued	—

SARISOL NO. 1

HALSEYANDA 084719—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	TABLET	ORAL	Discontinued	—
30MG	TABLET	ORAL	Discontinued	—

SODIUM BUTABARBITAL

HIKMAANDA 085418—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	TABLET	ORAL	Discontinued	—

SODIUM BUTABARBITAL

HIKMAANDA 085432—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG	TABLET	ORAL	Discontinued	—

SODIUM BUTABARBITAL

IVAX SUB TEVA PHARMSANDA 083484—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	TABLET	ORAL	Discontinued	—

SODIUM BUTABARBITAL

IVAX SUB TEVA PHARMSANDA 084040—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG	TABLET	ORAL	Discontinued	—

SODIUM BUTABARBITAL

LANNETTANDA 085849—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	TABLET	ORAL	Discontinued	—

SODIUM BUTABARBITAL

LANNETTANDA 085866—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG	TABLET	ORAL	Discontinued	—

SODIUM BUTABARBITAL

LANNETTANDA 085881—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Discontinued	—

SODIUM BUTABARBITAL

MARSHALL PHARMAANDA 083524—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
16.2MG	TABLET	ORAL	Discontinued	—

SODIUM BUTABARBITAL

MARSHALL PHARMAANDA 083858—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
32.4MG	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

Feb 09, 1982

45 yr 1 mo ago

Most recent approval

May 18, 1985

41 yr 9 mo ago

Approvals span 1982–1985 across 32 FDA applications.

Brand (NDA) 13%

Generic (ANDA) 3197%

Butabarbital sodium — 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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