FDA Product

Buspirone Hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Buspirone Hydrochloride

FDA Product Code

71335-1752

Regulatory Information

NDC Product Code

71335-1752

Application Number

ANDA075388

Marketing Category

C73584

Effective Date

May 26, 2023

Territorial Authority

USA

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

102

Company Information

ManufacturerBryant Ranch Prepack

DUNS Number

171714327

Active Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

BUSPIRONE HYDROCHLORIDE

Quantity: 15 mg in 1 1

Code: 207LT9J9OC

Class Code: ACTIB

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE 102

Code: PNR0YF693Y

Class Code: IACT

Active Moieties

BUSPIRONE

Code: TK65WKS8HL

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