NDC Code(s) : 49349-577-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FamotidineFamotidine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-577(NDC:64679-937)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE(UNII: 5QZO15J2Z8)
(FAMOTIDINE - UNII:5QZO15J2Z8) 		FAMOTIDINE40 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
Product Characteristics
Color white Score no score
Shape ROUND (barrel shape) Size 9 mm
Flavor Imprint Code W;937
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-577-0230 in 1 BLISTER PACK Type 0: Not a Combination Product17/09/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075786 09/17/2010 02/15/2013

PRINCIPAL DISPLAY PANEL

DRUG: Famotidine

GENERIC: Famotidine

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 49349-577-02

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 9 mm

IMPRINT: W;937

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • FAMOTIDINE 40mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • TALC
  • STARCH, CORN
  • TITANIUM DIOXIDE
  • HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
  • HYPROMELLOSES
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOL 400

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