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, for oral use, C-IVInitial U.S. Approval: 1992
Approved
Approval ID
f5962f3a-a693-4f5f-b2ec-25c298f375c0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 27, 2015
Manufacturers
FDA
Ranbaxy Pharmaceuticals Inc.
DUNS: 937890044
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 Code63304-159
Application NumberANDA078055
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zolpidem Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2015
FDA Product Classification
INGREDIENTS (11)
ZOLPIDEM TARTRATEActive
Quantity: 5 mg in 1 1
Code: WY6W63843K
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Zolpidem Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-160
Application NumberANDA078055
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zolpidem Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2015
FDA Product Classification
INGREDIENTS (10)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ZOLPIDEM TARTRATEActive
Quantity: 10 mg in 1 1
Code: WY6W63843K
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT