Zolpidem Tartrate
These highlights do not include all the information needed to use Zolpidem Tartrate Tablets, USP safely and effectively. See full prescribing information for Zolpidem Tartrate Tablets, USP. Zolpidem Tartrate Tablets, USP - CIV Initial U.S. Approval: 1992
Approved
Approval ID
f852e2c0-74fe-4389-ba96-d0c03f624c86
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 2, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
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 Code54868-0846
Application NumberANDA077884
Product Classification
M
Marketing Category
C73584
G
Generic Name
zolpidem tartrate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2012
FDA Product Classification
INGREDIENTS (8)
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Zolpidem TartrateActive
Quantity: 10 mg in 1 1
Code: WY6W63843K
Classification: ACTIB
zolpidem tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0845
Application NumberANDA077884
Product Classification
M
Marketing Category
C73584
G
Generic Name
zolpidem tartrate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2012
FDA Product Classification
INGREDIENTS (9)
Zolpidem TartrateActive
Quantity: 5 mg in 1 1
Code: WY6W63843K
Classification: ACTIB
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT