FDA Orange Book · active-ingredient family
Buspirone hydrochloride
Buspirone hydrochloride: 2 brands, 22 generics; first approved Sep 29, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 22 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
22
Listed patents
0
Presentations
101
Brand (NDA) products
Originator applications
- BUSPARRLDBRISTOL MYERS SQUIBBNDA 02119020004 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — 7.5MG CAPSULE ORAL Discontinued — 10MG CAPSULE ORAL Discontinued — 15MG CAPSULE ORAL Discontinued — - BUSPARRLDBRISTOL MYERS SQUIBBNDA 01873119864 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 15MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued —
Generic (ANDA) products (22)
Abbreviated applications
- BUSPIRONE HYDROCHLORIDEEPIC PHARMA LLCANDA 20897220267 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 7.5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx — 12.5MG TABLET ORAL Rx — - EPIC PHARMA LLCANDA 21862820264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG CAPSULE ORAL Rx — 10MG CAPSULE ORAL Rx — 15MG CAPSULE ORAL Rx — 5MG CAPSULE ORAL Rx — - BUSPIRONE HYDROCHLORIDEUNICHEMANDA 21090720194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - BUSPIRONE HYDROCHLORIDEINVENTIA HLTHCAREANDA 20969620185 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx BX 7.5MG TABLET ORAL Rx BX 10MG TABLET ORAL Rx BX 15MG TABLET ORAL Rx BX 30MG TABLET ORAL Rx BX - BUSPIRONE HYDROCHLORIDEAMNEAL PHARMS COANDA 20882920175 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 7.5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 15MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - BUSPIRONE HYDROCHLORIDEAIPING PHARM INCANDA 20208720155 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 7.5MG TABLET ORAL Rx AB - BUSPIRONE HYDROCHLORIDEHERITAGE PHARMAANDA 20458220154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - BUSPIRONE HYDROCHLORIDEACCORD HLTHCAREANDA 20255720145 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 7.5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - BUSPIRONE HYDROCHLORIDESTRIDES PHARMAANDA 20233020145 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 7.5MG TABLET ORAL Rx AB - BUSPIRONE HYDROCHLORIDEZYDUS PHARMSANDA 07888820145 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 7.5MG TABLET ORAL Rx AB - BUSPIRONE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 07824620095 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 7.5MG TABLET ORAL Rx AB - BUSPIRONE HYDROCHLORIDEOXFORD PHARMSANDA 0783022007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Rx AB - BUSPIRONE HYDROCHLORIDEOXFORD PHARMSANDA 07538820023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB - BUSPIRONE HYDROCHLORIDERUBICON RESEARCHANDA 07552120025 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 7.5MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - BUSPIRONE HYDROCHLORIDERISINGANDA 07541320025 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 7.5MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - BUSPIRONE HYDROCHLORIDEEGISANDA 07511920023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 15MG TABLET ORAL Discontinued — - BUSPIRONE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 07538520023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 15MG TABLET ORAL Discontinued — - BUSPIRONE HYDROCHLORIDEMYLANANDA 07600820025 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Rx AB 7.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB - BUSPIRONE HYDROCHLORIDEMYLANANDA 07546720024 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 7.5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 15MG TABLET ORAL Discontinued — - BUSPIRONE HYDROCHLORIDETEVAANDA 07502220024 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - BUSPIRONE HYDROCHLORIDENESHER PHARMSANDA 07557220023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 15MG TABLET ORAL Discontinued — - BUSPIRONE HYDROCHLORIDEIMPAX LABS INCANDA 07425320013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB
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
40 yr 5 mo ago
Most recent approval
3 mo ago
Approvals span 1986–2026 across 24 FDA applications.
Brand (NDA) 28%
Generic (ANDA) 2292%
Buspirone hydrochloride: 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
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 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.
