Lamivudine and Zidovudine (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

Lamivudine and Zidovudine Tabs USP 150 mg/300 mg 60s Label
(click image for full-size original)

Lamivudine and Zidovudine Tabs USP 150 mg/300 mg 60s Label Text

NDC 0093-5385 -06

LAMIVUDINE and

ZIDOVUDINE

Tablets USP

150 mg/300 mg

Rx only

60 TABLETS

TEVA

LAMIVUDINE AND ZIDOVUDINE
lamivudine and zidovudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76519-1005(NDC:0093-5385)
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
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 17mm
Flavor Imprint Code TV;TV;L2;L2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76519-1005-6 6 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079081 12/27/2011
Labeler — H.J. Harkins Company, Inc. (147681894)
Registrant — H.J. Harkins Company, Inc. (147681894)
Establishment
Name Address ID/FEI Operations
H.J. Harkins Company, Inc. 147681894 repack, relabel

Revised: 06/2012 H.J. Harkins Company, Inc.

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