NDC Code(s) : 40032-762-01, 40032-762-30, 40032-761-01, 40032-761-30
Packager : Novel Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ZOLPIDEM TARTRATEzolpidem tartrate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-762
Route of Administration SUBLINGUAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLPIDEM TARTRATE(UNII: WY6W63843K)
(ZOLPIDEM - UNII:7K383OQI23) 		ZOLPIDEM TARTRATE1.75 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE(UNII: FZ989GH94E)
MANNITOL(UNII: 3OWL53L36A)
POLYVINYL ACETATE PHTHALATE(UNII: 58QVG85GW3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM CARBONATE(UNII: 45P3261C7T)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
ASPARTAME(UNII: Z0H242BBR1)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
Product Characteristics
Color WHITE (WHITE TO OFF WHITE) Score no score
Shape ROUND Size 7 mm
Flavor SPEARMINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:40032-762-3030 in 1 CARTON 22/03/2016
1NDC:40032-762-011 in 1 POUCH
11 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204299 03/22/2016
ZOLPIDEM TARTRATEzolpidem tartrate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-761
Route of Administration SUBLINGUAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLPIDEM TARTRATE(UNII: WY6W63843K)
(ZOLPIDEM - UNII:7K383OQI23) 		ZOLPIDEM TARTRATE3.5 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE(UNII: FZ989GH94E)
MANNITOL(UNII: 3OWL53L36A)
POLYVINYL ACETATE PHTHALATE(UNII: 58QVG85GW3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM CARBONATE(UNII: 45P3261C7T)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
ASPARTAME(UNII: Z0H242BBR1)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
Product Characteristics
Color WHITE (WHITE TO OFF WHITE) Score no score
Shape ROUND Size 9 mm
Flavor SPEARMINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:40032-761-3030 in 1 CARTON 22/03/2016
1NDC:40032-761-011 in 1 POUCH
11 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204299 03/22/2016

LABELER - Novel Laboratories, Inc.(793518643)

REGISTRANT - Novel Laboratories, Inc.(793518643)

Establishment
Name Address ID/FEI Business Operations
Novel Laboratories, Inc. 793518643 ANALYSIS(40032-761, 40032-762), MANUFACTURE(40032-761, 40032-762)

PRINCIPAL DISPLAY PANEL

1.75 mg - Carton

Panel-1

1.75-car-1

Panel-2

1.75-car-1

3.5 mg – Carton

Panel-1

1.75-car-1

Panel-2

1.75-car-1

1.75 mg – Pouch

1.75-car-1

3.5 mg – Pouch

1.75-car-1

1.75 mg – Blister

1.75-car-1

3.5 mg – Blister

1.75-car-1