Lamivudine (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lamivudine Tablets USP, 150 mg
NDC: 33342-001-09 Pack count: 60’s Count

150-60s
(click image for full-size original)

Lamivudine Tablets USP, 300 mg
NDC: 33342-002-07 Pack count: 30’s Count

300mg-30s
(click image for full-size original)
LAMIVUDINE lamivudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33342-001
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 150 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white) Score 2 pieces
Shape CAPSULE (Biconvex Capsule Shaped) Size 14mm
Flavor Imprint Code ML1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33342-001-09 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090198 05/02/2019
LAMIVUDINE lamivudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33342-002
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 300 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color GRAY Score no score
Shape CAPSULE (Biconvex Capsule Shaped) Size 16mm
Flavor Imprint Code U27
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33342-002-07 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090198 05/02/2019
Labeler — Macleods Pharmaceuticals Limited (862128535)
Establishment
Name Address ID/FEI Operations
Macleods Pharmaceuticals Limited 918608365 ANALYSIS (33342-001), ANALYSIS (33342-002), LABEL (33342-001), LABEL (33342-002), MANUFACTURE (33342-001), MANUFACTURE (33342-002), PACK (33342-001), PACK (33342-002)

Revised: 09/2020 Macleods Pharmaceuticals Limited

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