NDC Code(s) : 61786-320-12
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LamivudineLamivudine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-320(NDC:31722-753)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMIVUDINE(UNII: 2T8Q726O95)
(LAMIVUDINE - UNII:2T8Q726O95) 		LAMIVUDINE150 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE(UNII: 68401960MK)
ISOMALT(UNII: S870P55O2W)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHYLENE CHLORIDE(UNII: 588X2YUY0A)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score 2 pieces
Shape CAPSULE (biconvex) Size 15 mm
Flavor Imprint Code J;16
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-320-128 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203277 06/03/2015

PRINCIPAL DISPLAY PANEL

DRUG: Lamivudine

GENERIC: Lamivudine

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 61786-320-12

COLOR: white

SHAPE: CAPSULE

SCORE: Two even pieces

SIZE: 15 mm

IMPRINT: J;16

PACKAGING: 8 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • LAMIVUDINE 150mg in 1

INACTIVE INGREDIENT(S):

  • CROSPOVIDONE
  • POLYETHYLENE GLYCOLS
  • HYPROMELLOSES
  • POLYSORBATE 80
  • METHYLENE CHLORIDE
  • ISOMALT
  • ISOPROPYL ALCOHOL
  • MAGNESIUM STEARATE
  • TITANIUM DIOXIDE

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