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Buspirone Hydrochloride

Buspirone Hydrochloride

Approved
Approval ID

4b044819-2959-4914-b564-d944201246fd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 10, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Buspirone Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-195
Application NumberANDA076008
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2006
FDA Product Classification

INGREDIENTS (7)

BUSPIRONE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

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Buspirone Hydrochloride - FDA Drug Approval Details