NDC Code(s) : 52125-352-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Potassium ChloridePotassium Chloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-352(NDC:68382-600)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
(POTASSIUM CATION - UNII:295O53K152) 		POTASSIUM CHLORIDE750 mg
Inactive Ingredients
Ingredient Name Strength
CASTOR OIL(UNII: D5340Y2I9G)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
PARAFFIN(UNII: I9O0E3H2ZE)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
VANILLIN(UNII: CHI530446X)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
POLYVINYL ACETATE(UNII: 32K497ZK2U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color yellow Score no score
Shape OVAL Size 15 mm
Flavor Imprint Code a;KTAB
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-352-0230 in 1 BLISTER PACK Type 0: Not a Combination Product10/12/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA018279 12/10/2012

PRINCIPAL DISPLAY PANEL

DRUG: Potassium Chloride

GENERIC: Potassium Chloride

DOSAGE: TABLET, FILM COATED, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 52125-352-02

COLOR: yellow

SHAPE: OVAL

SCORE: No score

SIZE: 15 mm

IMPRINT: a;KTAB

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • POTASSIUM CHLORIDE 750mg in 1

INACTIVE INGREDIENT(S):

  • .ALPHA.-TOCOPHEROL
  • CASTOR OIL
  • ETHYLCELLULOSES
  • POLYVINYL ACETATE
  • VANILLIN
  • D&C YELLOW NO. 10
  • MAGNESIUM STEARATE
  • SILICON DIOXIDE
  • PARAFFIN
  • TITANIUM DIOXIDE

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