Buspirone Hydrochloride
Approved
Approval ID
a39912ab-2468-4229-84f5-3a21df650ade
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2015
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6455
Application NumberANDA075467
Product Classification
M
Marketing Category
C73584
G
Generic Name
buspirone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 4, 2015
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