NDC Code(s) : 35356-645-15, 35356-645-30, 35356-645-60, 35356-645-90, 35356-745-15, 35356-745-30, 35356-745-60, 35356-745-90
Packager : Lake Erie Medical DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Zolpidem Tartratezolpidem tartrate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-645(NDC:0054-0086)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLPIDEM TARTRATE(UNII: WY6W63843K)
(ZOLPIDEM - UNII:7K383OQI23) 		ZOLPIDEM TARTRATE5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSES(UNII: 3NXW29V3WO)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color PINK (Film-coated) Score no score
Shape ROUND (Biconvex) Size 7 mm
Flavor Imprint Code 54;371
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-645-1515 in 1 BOTTLE Type 0: Not a Combination Product27/04/2007
2NDC:35356-645-3030 in 1 BOTTLE Type 0: Not a Combination Product27/04/2007
3NDC:35356-645-6060 in 1 BOTTLE Type 0: Not a Combination Product27/04/2007
4NDC:35356-645-9090 in 1 BOTTLE Type 0: Not a Combination Product27/04/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077214 04/27/2007 01/01/2014
Zolpidem Tartratezolpidem tartrate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-745(NDC:0054-0087)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLPIDEM TARTRATE(UNII: WY6W63843K)
(ZOLPIDEM - UNII:7K383OQI23) 		ZOLPIDEM TARTRATE10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSES(UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color WHITE (fim-coated) Score no score
Shape ROUND (biconvex) Size 7 mm
Flavor Imprint Code 54;553
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-745-1515 in 1 BOTTLE Type 0: Not a Combination Product27/04/2007
2NDC:35356-745-3030 in 1 BOTTLE Type 0: Not a Combination Product27/04/2007
3NDC:35356-745-6060 in 1 BOTTLE Type 0: Not a Combination Product27/04/2007
4NDC:35356-745-9090 in 1 BOTTLE Type 0: Not a Combination Product27/04/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077214 04/27/2007

PRINCIPAL DISPLAY PANEL

Image of 5mg Label

PRINCIPAL DISPLAY PANEL

Image of 10mg Label