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)
1
Generics (ANDA)
30
Listed patents
0
Presentations
39
Brand (NDA) products
Originator applications
- 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 —
Generic (ANDA) products (30)
Abbreviated applications
- BUTABARBITAL SODIUMTEVAANDA 0886321985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — - BUTABARBITAL SODIUMTEVAANDA 0886311985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued — - BUTABARBITAL SODIUMSANDOZANDA 0842921982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — - 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 — - ALPHARMA US PHARMSANDA 085873—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/5ML ELIXIR ORAL Discontinued — - BUTABARBITAL SODIUMWOCKHARDTANDA 085383—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/5ML ELIXIR ORAL Discontinued — - LANNETTANDA 085880—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 33.3MG/5ML ELIXIR ORAL Discontinued — - MEDA PHARMSANDA 085380—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/5ML ELIXIR ORAL Discontinued — - HALSEYANDA 084723—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/5ML ELIXIR ORAL Discontinued — - BUNDYANDA 085550—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued — - BUTABARBITAL SODIUMRLDSANDOZANDA 085938—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — - BUTABARBITAL SODIUMSANDOZANDA 084272—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued — - BUTABARBITAL SODIUMSANDOZANDA 085934—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued — - BUTABARBITAL SODIUMSOLVAYANDA 083606—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 16.2MG TABLET ORAL Discontinued — - BUTABARBITAL SODIUMSOLVAYANDA 083898—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 32.4MG TABLET ORAL Discontinued — - BUTABARBITAL SODIUMSOLVAYANDA 083897—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 48.6MG TABLET ORAL Discontinued — - BUTABARBITAL SODIUMSOLVAYANDA 083896—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 97.2MG TABLET ORAL Discontinued — - BUTABARBITAL SODIUMWATSON LABSANDA 085764—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — - BUTABARBITAL SODIUMWATSON LABSANDA 085772—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued — - BUTABARBITAL SODIUMWHITEWORTH TOWN PLSNANDA 083325—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — - BUTABARBITAL SODIUMWHITEWORTH TOWN PLSNANDA 083337—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued — - HALSEYANDA 084719—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - HIKMAANDA 085418—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - IVAX SUB TEVA PHARMSANDA 083484—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — - IVAX SUB TEVA PHARMSANDA 084040—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued — - LANNETTANDA 085849—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — - LANNETTANDA 085866—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued — - LANNETTANDA 085881—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - MARSHALL PHARMAANDA 083524—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 16.2MG TABLET ORAL Discontinued — - MARSHALL PHARMAANDA 083858—
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
First approval
45 yr 4 mo ago
Most recent approval
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.
Related FDA reference tools
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- 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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