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 tablet for oral use - CIVInitial U.S. Approval: 1992
Approved
Approval ID
7efb19d9-32bb-4737-ac7f-2ec21eca255c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2009
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
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 Code21695-507
Application NumberANDA077903
Product Classification
M
Marketing Category
C73584
G
Generic Name
zolpidem tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2009
FDA Product Classification
INGREDIENTS (1)
ZOLPIDEM TARTRATEActive
Quantity: 10 mg in 1 1
Code: WY6W63843K
Classification: ACTIB