ALPRAZOLAM
ALPRAZOLAM Tablets, USP
Approved
Approval ID
175cad46-c9ac-4dd6-a31a-65591b85f899
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2012
Manufacturers
FDA
Life Line Home Care Services, Inc.
DUNS: 844985374
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Alprazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75921-901
Application NumberANDA074174
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2012
FDA Product Classification
INGREDIENTS (9)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
AlprazolamActive
Quantity: 0.5 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT