Prescription Drug Information: ZOLPIDEM TARTRATE (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

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ZOLPIDEM TARTRATE zolpidem tartrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-1887(NDC:13668-008)
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
FERRIC OXIDE RED
Product Characteristics
Color yellow (peach-yellow) Score no score
Shape CAPSULE (Capsule) Size 10mm
Flavor Imprint Code 10MG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-1887-1 10 TABLET in 1 BOTTLE None
2 NDC:68071-1887-5 15 TABLET in 1 BOTTLE None
3 NDC:68071-1887-8 28 TABLET in 1 BOTTLE None
4 NDC:68071-1887-4 14 TABLET in 1 BOTTLE None
5 NDC:68071-1887-2 20 TABLET in 1 BOTTLE None
6 NDC:68071-1887-3 30 TABLET in 1 BOTTLE None
7 NDC:68071-1887-6 60 TABLET in 1 BOTTLE None
8 NDC:68071-1887-9 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077903 09/05/2007
Labeler — NuCare Pharmaceuticals, Inc (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals, Inc. 010632300 repack (68071-1887)

Revised: 07/2023 NuCare Pharmaceuticals, Inc

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