LAMIVUDINE AND ZIDOVUDINE (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LAMIVUDINE AND ZIDOVUDINE TABLETS USP

Rx only

150 mg/300 mg

NDC 68180-284-07

BOTTLE LABEL: 60 TABLETS

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label-pth
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LAMIVUDINE AND ZIDOVUDINE lamivudine and zidovudine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-284
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score 2 pieces
Shape CAPSULE (modified-capsule) Size 18mm
Flavor Imprint Code LU;Y01
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-284-07 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090246 05/15/2012
Labeler — LUPIN LIMITED (675923163)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 677600414 manufacture (57297-284), pack (57297-284)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 863645527 manufacture (57297-284), pack (57297-284)

Revised: 06/2016 LUPIN LIMITED

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