Zolpidem
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
021153ce-fe27-4ed1-8d88-b4157b0ed734
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2023
Manufacturers
FDA
ACI Healthcare USA, Inc
DUNS: 080430318
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 Code71093-156
Application NumberANDA077214
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zolpidem Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (11)
ZOLPIDEM TARTRATEActive
Quantity: 10 mg in 1 1
Code: WY6W63843K
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Zolpidem Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71093-155
Application NumberANDA077214
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zolpidem Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (14)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
ZOLPIDEM TARTRATEActive
Quantity: 5 mg in 1 1
Code: WY6W63843K
Classification: ACTIB
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT