Prescription Drug Information: Abacavir and Lamivudine

ABACAVIR AND LAMIVUDINE- abacavir sulfate and lamivudine tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1053-9

Abacavir and Lamivudine Tablets, 600 mg/300 mg

90 Tablets

Rx only

abacavir sulfate and lamivudine tablet
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Abacavir Sulfate and Lamivudine Tablet:

Warning Card

abacavir sulfate and lamivudine tablet
(click image for full-size original)
ABACAVIR AND LAMIVUDINE
abacavir and lamivudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1053
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
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C RED NO. 40
FERRIC OXIDE YELLOW
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE K30
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (LIGHT YELLOW TO YELLOW) Score no score
Shape CAPSULE (CAPSULE) Size 20mm
Flavor Imprint Code 1049
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1053-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1053-9 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208990 03/14/2019
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 863362789 ANALYSIS (70771-1053), MANUFACTURE (70771-1053)

Revised: 07/2020 Cadila Healthcare Limited

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