NDC Code(s) : 52125-864-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LamotrigineLamotrigine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-864(NDC:29300-113)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE(UNII: U3H27498KS)
(LAMOTRIGINE - UNII:U3H27498KS) 		LAMOTRIGINE150 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE K29/32(UNII: 390RMW2PEQ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color white Score 2 pieces
Shape TRIANGLE (Trigonal) Size 12 mm
Flavor Imprint Code U;U;113
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-864-0230 in 1 BLISTER PACK Type 0: Not a Combination Product11/03/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090170 03/11/2014

PRINCIPAL DISPLAY PANEL

DRUG: Lamotrigine

GENERIC: Lamotrigine

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 52125-864-02

COLOR: white

SHAPE: TRIANGLE

SCORE: Two even pieces

SIZE: 12 mm

IMPRINT: U;U;113

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • LAMOTRIGINE 150mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • POVIDONE K29/32
  • MAGNESIUM STEARATE
  • LACTOSE MONOHYDRATE
  • SODIUM STARCH GLYCOLATE TYPE A POTATO

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