Abacavir and Lamivudine: Package Insert and Label Information (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton
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label
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ABACAVIR AND LAMIVUDINE abacavir and lamivudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-362
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ABACAVIR SULFATE (ABACAVIR) ABACAVIR 600 mg
LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 300 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE B POTATO
HYPROMELLOSES
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
FD&C YELLOW NO. 6
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE Score no score
Shape OVAL (capsule shaped) Size 21mm
Flavor Imprint Code C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69097-362-02 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091144 03/28/2017
Labeler — Cipla USA Inc. (078719707)
Registrant — Cipla USA Inc. (078719707)
Establishment
Name Address ID/FEI Operations
Cipla Ltd. Patalganga unit II 916940208 ANALYSIS (69097-362), LABEL (69097-362), MANUFACTURE (69097-362), PACK (69097-362)

Revised: 01/2022 Cipla USA Inc.

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