Alprazolam
ALPRAZOLAM TABLETS, USP0.25 mg, 0.5 mg, 1 mg and 2 mg
Approved
Approval ID
0d97256b-77f5-405e-b5be-cded19653180
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 13, 2012
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
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 Code66336-932
Application NumberANDA078491
Product Classification
M
Marketing Category
C73584
G
Generic Name
alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 13, 2012
FDA Product Classification
INGREDIENTS (9)
ALPRAZOLAMActive
Quantity: 1 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 12/5/2011
Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811
8182238
R11/11-R4