Buspirone Hydrochloride
Approved
Approval ID
65c69118-36bb-4f0d-9669-b52556056ec5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code63629-2413
Application NumberANDA075388
Product Classification
M
Marketing Category
C73584
G
Generic Name
buspirone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2020
FDA Product Classification
INGREDIENTS (6)
BUSPIRONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT