BUSPIRONE HYDROCHLORIDE

Basic Information

Product Name

FDA Product Code

50090-7075

Regulatory Information

NDC Product Code

50090-7075

Application Number

ANDA078246

Marketing Category

C73584

Effective Date

July 5, 2021

Territorial Authority

USA

FDA Title

Buspirone Hydrochloride Tablets, USP Rx only (Patient Instruction Sheet Included)

Labeling Type

Human Prescription Drug Label

Version Number

Active Ingredients

BUSPIRONE HYDROCHLORIDE

Quantity: 7.5 mg in 1 1

Code: 207LT9J9OC

Class Code: ACTIB

Inactive Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

Active Moieties

BUSPIRONE

Code: TK65WKS8HL

Basic Information

Regulatory Information

Company Information

Active Ingredients

Inactive Ingredients

LACTOSE MONOHYDRATE

SILICON DIOXIDE

MICROCRYSTALLINE CELLULOSE

MAGNESIUM STEARATE

SODIUM STARCH GLYCOLATE TYPE A POTATO

Active Moieties

BUSPIRONE