ZOLPIDEM TARTRATE

Basic Information

Product Name

ZOLPIDEM TARTRATE

FDA Product Code

16590-528

Regulatory Information

NDC Product Code

16590-528

Application Number

ANDA077903

Marketing Category

C73584

Effective Date

July 12, 2011

Territorial Authority

USA

FDA Title

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, USP -CIVInitial U.S. Approval: 1992

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

ZOLPIDEM TARTRATE

Quantity: 5 mg in 1 1

Code: WY6W63843K

Class Code: ACTIB

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYETHYLENE GLYCOLS

Code: 3WJQ0SDW1A

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

Active Moieties

ZOLPIDEM

Code: 7K383OQI23

Basic Information

Regulatory Information

Company Information

Active Ingredients

LACTOSE MONOHYDRATE

HYPROMELLOSES

CELLULOSE, MICROCRYSTALLINE

MAGNESIUM STEARATE

POLYETHYLENE GLYCOLS

TITANIUM DIOXIDE

SODIUM STARCH GLYCOLATE TYPE A POTATO

FERRIC OXIDE RED

Active Moieties

ZOLPIDEM