Buspirone Hydrochloride
BusPIRone Hydrochloride Tablets USP Rx only
Approved
Approval ID
4adc1750-b89e-473d-a18f-949423a2354f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-4862
Application NumberANDA075022
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2016
FDA Product Classification
INGREDIENTS (6)
BUSPIRONE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT