AMBIEN
These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN Ambien® (zolpidem tartrate) tablets CIVInitial U.S. Approval: 1992
Approved
Approval ID
02b5e3bb-c976-40a3-9077-64ffe637429f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 18, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 2
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 Code16590-010
Application NumberNDA019908
Product Classification
M
Marketing Category
C73594
G
Generic Name
ZOLPIDEM TARTRATE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2012
FDA Product Classification
INGREDIENTS (7)
ZOLPIDEM TARTRATEActive
Quantity: 10 mg in 1 1
Code: WY6W63843K
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ZOLPIDEM TARTRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-009
Application NumberNDA019908
Product Classification
M
Marketing Category
C73594
G
Generic Name
ZOLPIDEM TARTRATE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2012
FDA Product Classification
INGREDIENTS (9)
ZOLPIDEM TARTRATEActive
Quantity: 5 mg in 1 1
Code: WY6W63843K
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT