MedPath

Buspirone Hydrochloride

Rx only

Approved
Approval ID

5424f933-93e1-4480-acdf-bd8667ae50e9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 4, 2023

Manufacturers
FDA

Cardinal Health 107, LLC

DUNS: 118546603

Products 2

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 Code55154-4312
Application NumberANDA204582
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 4, 2023
FDA Product Classification

INGREDIENTS (6)

ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
BUSPIRONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

Buspirone Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55154-4305
Application NumberANDA204582
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 4, 2023
FDA Product Classification

INGREDIENTS (6)

BUSPIRONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

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Buspirone Hydrochloride - FDA Drug Approval Details