Lamivudine (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lamivudine Tablets 150 mg

Bottle of 60 Tablets

68180-602-07

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Lamivudine Tablets 300 mg

Bottle of 30 Tablets

68180-603-06

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LAMIVUDINE lamivudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-602
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape CAPSULE Size 14mm
Flavor Imprint Code L;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-602-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68180-602-07 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205217 03/25/2015
LAMIVUDINE lamivudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-603
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
FERROSOFERRIC OXIDE
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
TITANIUM DIOXIDE
Product Characteristics
Color GRAY Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code L;6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-603-06 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205217 03/25/2015
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 677600414 MANUFACTURE (68180-602), MANUFACTURE (68180-603), PACK (68180-602), PACK (68180-603)

Revised: 10/2023 Lupin Pharmaceuticals, Inc.

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