Zolpidem (Page 8 of 8)

PRINCIPAL DISPLAY PANEL —

pdp
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ZOLPIDEM zolpidem tartrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-2774(NDC:71093-156)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLPIDEM TARTRATE (ZOLPIDEM) ZOLPIDEM TARTRATE 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MICROCRYSTALLINE CELLULOSE 102
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
POLYDEXTROSE
TITANIUM DIOXIDE
TRIACETIN
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color white Score no score
Shape ROUND (biconvex) Size 7mm
Flavor Imprint Code IT118
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-2774-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077214 09/24/2020
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 relabel (68071-2774)

Revised: 06/2022 NuCare Pharmaceuticals,Inc.

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