Zolpidem Tartrate
These highlights do not include all the information needed to use Zolpidem Tartrate safely and effectively. See full prescribing information for Zolpidem Tartrate. Zolpidem Tartrate (Zolpidem Tartrate) TABLET, FILM COATED, EXTENDED RELEASE for ORAL use.Initial U.S. Approval: 1992
Approved
Approval ID
4735f5c3-3038-4e1b-9fe4-47158550f14b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 9, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6189
Application NumberANDA078179
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zolpidem Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2010
FDA Product Classification
INGREDIENTS (16)
ZOLPIDEM TARTRATEActive
Quantity: 6.25 mg in 1 1
Code: WY6W63843K
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT