Zolpidem Tartrate
These highlights do not include all the information needed to use ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS. ZOLPIDEM TARTRATE extended-release tablets, for oral use, C-IV Initial U.S. Approval: 1992
Approved
Approval ID
ebd6c66b-b230-48d7-b38f-d610b6cb2b6c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 2, 2019
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code71610-254
Application NumberANDA204170
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zolpidem Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 26, 2019
FDA Product Classification
INGREDIENTS (16)
ZOLPIDEM TARTRATEActive
Quantity: 12.5 mg in 1 1
Code: WY6W63843K
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT