Is there a generic for Butabarbital sodium?

Yes. The FDA Orange Book lists 30 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, 30 generics; first approved Feb 09, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 30 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

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BUTISOL SODIUMRLD
PHARMOBEDIENTNDA 000793-4 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG TABLET ORAL Discontinued -
50MG TABLET ORAL Discontinued -
30MG TABLET ORAL Discontinued -
100MG TABLET ORAL Discontinued -

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

Generic (ANDA) products (30)

Abbreviated applications

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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 085418-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG TABLET ORAL Discontinued -
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 -

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

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

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

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	-

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Listed patents

Orange Book patent file

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

FDA approval span

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First approval

Feb 09, 1982

45 yr 4 mo ago

Most recent approval

May 18, 1985

42 yr ago

Approvals span 1982–1985 across 31 FDA applications.

Brand (NDA) 13%

Generic (ANDA) 3097%

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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