Lamivudine and Zidovudine (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

NDC 76282-115-60

Lamivudine and Zidovudine Tablets, USP 150/300 mg

Rx only 60 Tablets

EXELAN PHARMACEUTICALS, INC.

7.5mg-100
(click image for full-size original)
LAMIVUDINE AND ZIDOVUDINE lamivudine and zidovudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-115
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, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off-white) Score 2 pieces
Shape CAPSULE (Capsule Shaped, Biconvex) Size 18mm
Flavor Imprint Code T;115
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-115-60 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:76282-115-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203259 04/29/2015
Labeler — Exelan Pharmaceuticals Inc. (967795266)
Establishment
Name Address ID/FEI Operations
Ascent Pharmaceuticals Inc. 080938961 manufacture (76282-115), analysis (76282-115)

Revised: 01/2019 Exelan Pharmaceuticals Inc.

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