ALPRAZOLAM
Alprazolam Extended-Release Tablets CIV0.5 mg, 1 mg, 2 mg and 3 mg Rx only
Approved
Approval ID
4f6c075f-e2b7-41fa-82c7-eba85cbe27a3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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 Code52959-965
Application NumberANDA077996
Product Classification
M
Marketing Category
C73584
G
Generic Name
ALPRAZOLAM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2011
FDA Product Classification
INGREDIENTS (6)
ALPRAZOLAMActive
Quantity: 1 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIR
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT