BUSPIRONE HYDROCHLORIDE
Approved
Approval ID
b3240f73-c506-4591-a441-3bfab2fb1281
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 19, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 Code16590-727
Application NumberANDA075467
Product Classification
M
Marketing Category
C73584
G
Generic Name
BUSPIRONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 19, 2010
FDA Product Classification
INGREDIENTS (6)
BUSPIRONE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT