zolpidem tartrate
These highlights do not include all the information needed to use ZOLPIDEM TARTRATE CAPSULES safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE CAPSULES. ZOLPIDEM TARTRATE capsules, for oral use, CIV Initial U.S. Approval: 1992
Approved
Approval ID
2f1a3600-9bd6-3651-3ab5-1e4e0b0a3916
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 10, 2023
Manufacturers
FDA
Almatica Pharma LLC
DUNS: 962454505
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52427-775
Application NumberNDA215721
Product Classification
M
Marketing Category
C73594
G
Generic Name
zolpidem tartrate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2020
FDA Product Classification
INGREDIENTS (10)
ZOLPIDEM TARTRATEActive
Quantity: 7.5 mg in 1 1
Code: WY6W63843K
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT