Prescription Drug Information: Abacavir (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label
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carton
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ABACAVIR abacavir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-514
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ABACAVIR SULFATE (ABACAVIR) ABACAVIR 300 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A CORN
STARCH, CORN
MAGNESIUM STEARATE
SILICON DIOXIDE
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (3 MPA.S)
POLYETHYLENE GLYCOL 400
FERRIC OXIDE YELLOW
POLYSORBATE 80
Product Characteristics
Color YELLOW Score 2 pieces
Shape CAPSULE Size 19mm
Flavor Imprint Code 5;14
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69097-514-03 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078119 11/21/2017
Labeler — Cipla USA Inc. (078719707)
Registrant — Cipla USA Inc. (078719707)
Establishment
Name Address ID/FEI Operations
Cipla Patalganga 916940208 ANALYSIS (69097-514), LABEL (69097-514), MANUFACTURE (69097-514), PACK (69097-514)
Establishment
Name Address ID/FEI Operations
Cipla Kurkumbh 917066446 API MANUFACTURE (69097-514)
Establishment
Name Address ID/FEI Operations
Mylan-Laboratories Limited 650438158 API MANUFACTURE (69097-514)

Revised: 12/2020 Cipla USA Inc.

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