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Buspirone Hydrochloride

Buspirone Hydrochloride Tablets, USP (Patient Instruction Sheet Included)

Approved
Approval ID

d9de7cf1-c38d-8b3c-e053-2995a90aa26b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 18, 2023

Manufacturers
FDA

Northwind Pharmaceuticals

DUNS: 036986393

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 Code51655-796
Application NumberANDA202330
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2023
FDA Product Classification

INGREDIENTS (7)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BUSPIRONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB

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Buspirone Hydrochloride - FDA Drug Approval Details