LAMIVUDINE and ZIDOVUDINE (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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LAMIVUDINE AND ZIDOVUDINE lamivudine and zidovudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-4450(NDC:31722-506)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 150 mg
ZIDOVUDINE (ZIDOVUDINE) ZIDOVUDINE 300 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score 2 pieces
Shape CAPSULE Size 18mm
Flavor Imprint Code H;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-4450-6 6 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079124 09/18/2015
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-4450)

Revised: 02/2021 NuCare Pharmaceuticals,Inc.

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