Zolpidem (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 10 mg Bottle Label

NDC: 70934-917-30

Label
(click image for full-size original)
ZOLPIDEM zolpidem tartrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70934-917(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:70934-917-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077214 11/01/2021
Labeler — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Registrant — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Establishment
Name Address ID/FEI Operations
Denton Pharma, Inc. DBA Northwind Pharmaceuticals 080355546 repack (70934-917)

Revised: 11/2021 Denton Pharma, Inc. DBA Northwind Pharmaceuticals

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