NDC Code(s) : 61786-622-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Isosorbide Dinitrateisosorbide dinitrate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-622(NDC:49884-021)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOSORBIDE DINITRATE(UNII: IA7306519N)
(ISOSORBIDE DINITRATE - UNII:IA7306519N) 		ISOSORBIDE DINITRATE10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A CORN(UNII: AG9B65PV6B)
STEARIC ACID(UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 8 mm
Flavor Imprint Code Par;021
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-622-0230 in 1 BLISTER PACK Type 0: Not a Combination Product16/03/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086925 03/16/2016

PRINCIPAL DISPLAY PANEL

DRUG: Isosorbide Dinitrate

GENERIC: isosorbide dinitrate

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 61786-622-02

COLOR: white

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 8 mm

IMPRINT: Par;021

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • ISOSORBIDE DINITRATE 10mg in 1

INACTIVE INGREDIENT(S):

  • ANHYDROUS LACTOSE
  • STEARIC ACID
  • MAGNESIUM STEARATE
  • MICROCRYSTALLINE CELLULOSE
  • SODIUM STARCH GLYCOLATE TYPE A CORN

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