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 tablets Zolpidem Tartrate Tablets, for oral use CIV Initial U.S. Approval: 1992
Approved
Approval ID
cace3d8a-cbb5-4072-9bce-28219b4909ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 10, 2014
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code43353-617
Application NumberANDA078616
Product Classification
M
Marketing Category
C73584
G
Generic Name
zolpidem tartrate
Product Specifications
Route of AdministrationORAL
Effective DateApril 10, 2014
FDA Product Classification
INGREDIENTS (9)
ZOLPIDEM TARTRATEActive
Quantity: 10 mg in 1 1
Code: WY6W63843K
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
zolpidem tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-620
Application NumberANDA078616
Product Classification
M
Marketing Category
C73584
G
Generic Name
zolpidem tartrate
Product Specifications
Route of AdministrationORAL
Effective DateApril 10, 2014
FDA Product Classification
INGREDIENTS (12)
ZOLPIDEM TARTRATEActive
Quantity: 5 mg in 1 1
Code: WY6W63843K
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT