NDC Code(s) : 61786-921-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Calcium Polycarbophil 625 mgCalcium Polycarbophil 625 mg TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-921(NDC:69618-030)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM POLYCARBOPHIL(UNII: 8F049NKY49)
(POLYCARBOPHIL - UNII:W25LM17A4W) 		CALCIUM POLYCARBOPHIL625 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CAROB(UNII: 5MG5Z946UO)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 19 mm
Flavor Imprint Code AP;067
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-921-0230 in 1 BLISTER PACK Type 0: Not a Combination Product10/06/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 10/06/2016

PRINCIPAL DISPLAY PANEL

DRUG: Calcium Polycarbophil 625 mg

GENERIC: Calcium Polycarbophil 625 mg

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 61786-921-02

COLOR: white

SHAPE: OVAL

SCORE: Two even pieces

SIZE: 19 mm

IMPRINT: AP;067

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • CALCIUM POLYCARBOPHIL 625mg in 1

INACTIVE INGREDIENT(S):

  • CAROB
  • CELLULOSE, MICROCRYSTALLINE
  • SILICON DIOXIDE
  • CROSCARMELLOSE SODIUM
  • HYPROMELLOSES
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOL 1000

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