AMBIEN
These highlights do not include all the information needed to use Ambien CR safely and effectively. See full prescribing information for Ambien CR. Ambien CR (zolpidem tartrate extended-release) tablets - CIVInitial U.S. Approval: 1992
Approved
Approval ID
40f9a7b1-b57b-4e70-b709-e81705e784a7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
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
NDC Product Code16590-436
Application NumberNDA021774
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateApril 30, 2012
Generic NameZOLPIDEM TARTRATE
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ZOLPIDEM TARTRATEActive
Quantity: 12.5 mg in 1 1
Code: WY6W63843K
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POTASSIUM BITARTRATEInactive
Code: NPT6P8P3UU
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT