Zolpidem Tartrate
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 CIV Initial U.S. Approval: 1992
Approved
Approval ID
e617f7f2-585c-4eb5-8d35-1fc6d02ef57d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2012
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
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 Code66336-718
Application NumberANDA078616
Product Classification
M
Marketing Category
C73584
G
Generic Name
zolpidem tartrate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2012
FDA Product Classification
INGREDIENTS (9)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ZOLPIDEM TARTRATEActive
Quantity: 10 mg in 1 1
Code: WY6W63843K
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT