ZOLPIDEM TARTRATE
These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETSZolpidem tartrate tablets, USP -CIVInitial U.S. Approval: 1992
Approved
Approval ID
9245ff4b-a11f-4afd-8fa0-842fcfee4306
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 18, 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.
zolpidem tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-880
Application NumberANDA077903
Product Classification
M
Marketing Category
C73584
G
Generic Name
zolpidem tartrate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2011
FDA Product Classification
INGREDIENTS (1)
ZOLPIDEM TARTRATEActive
Quantity: 10 mg in 1 1
Code: WY6W63843K
Classification: ACTIB