FDA Orange Book

Generic for Buspar

Buspar contains buspirone. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Buspar is buspirone. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Buspar products in the Orange Book

Buspar products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oral10MGDiscontinuedNone1None
capsule, oral15MGDiscontinuedNone1None
capsule, oral5MGDiscontinuedNone1None
capsule, oral7.5MGDiscontinuedNone1None
tablet, oral10MGDiscontinuedNone15AB
tablet, oral15MGDiscontinuedNone15AB
tablet, oral30MGDiscontinuedNone14AB
tablet, oral5MGDiscontinuedNone15AB

NDA 021190, 018731, held by BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic buspirone

Approved generic versions of Buspar
CompanyANDATE codeApprovedStrengths
IMPAX LABORATORIES INC074253AB (A-rated, therapeutically equivalent)March 28, 200110MG, 15MG, 5MG
TEVA PHARMACEUTICALS USA INC075022AB (A-rated, therapeutically equivalent)February 28, 200210MG, 15MG, 30MG, 5MG
MYLAN PHARMACEUTICALS INC076008AB (A-rated, therapeutically equivalent)March 1, 200210MG, 15MG, 30MG, 5MG
RISING PHARMA HOLDINGS INC075413AB (A-rated, therapeutically equivalent)March 19, 200210MG, 15MG, 30MG, 5MG
RUBICON RESEARCH LTD075521AB (A-rated, therapeutically equivalent)April 5, 200210MG, 15MG, 30MG, 5MG
OXFORD PHARMACEUTICALS LLC075388AB (A-rated, therapeutically equivalent)May 9, 200210MG, 15MG, 5MG
OXFORD PHARMACEUTICALS LLC078302AB (A-rated, therapeutically equivalent)December 17, 200730MG
AUROBINDO PHARMA LTD078246AB (A-rated, therapeutically equivalent)February 27, 200910MG, 15MG, 30MG, 5MG
ZYDUS PHARMACEUTICALS USA INC078888AB (A-rated, therapeutically equivalent)February 7, 201410MG, 15MG, 30MG, 5MG
STRIDES PHARMA GLOBAL PTE LTD202330AB (A-rated, therapeutically equivalent)August 25, 201410MG, 15MG, 30MG, 5MG
ACCORD HEALTHCARE INC202557AB (A-rated, therapeutically equivalent)December 30, 201410MG, 15MG, 30MG, 5MG
HERITAGE PHARMA LABS INC204582AB (A-rated, therapeutically equivalent)September 18, 201510MG, 15MG, 30MG, 5MG
AIPING PHARMACEUTICAL INC202087AB (A-rated, therapeutically equivalent)December 16, 201510MG, 15MG, 30MG, 5MG
ADAPTIS PHARMA PRIVATE LTD209696AB (A-rated, therapeutically equivalent)May 3, 201810MG, 15MG, 30MG, 5MG
EPIC PHARMA LLC208972AB (A-rated, therapeutically equivalent)April 16, 201910MG, 15MG, 30MG, 5MG
UNICHEM LABORATORIES LTD210907AB (A-rated, therapeutically equivalent)November 14, 201910MG, 15MG, 30MG, 5MG
EPIC PHARMA LLC218628None (No TE code listed)March 13, 202510MG, 15MG, 5MG, 7.5MG

Questions

Is there a generic for Buspar?

Yes. The generic name for Buspar is buspirone. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Buspar?

The active ingredient in Buspar is buspirone, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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