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