NDC Code(s) : 72789-057-30
Packager : PD-Rx Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

POTASSIUM CHLORIDEPOTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-057(NDC:63304-090)
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
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
Product Characteristics
Color blue (light blue) Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code 103
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72789-057-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product28/07/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208864 01/02/2020

LABELER - PD-Rx Pharmaceuticals, Inc.(156893695)

REGISTRANT - PD-Rx Pharmaceuticals, Inc.(156893695)

Establishment
Name Address ID/FEI Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack(72789-057)

PRINCIPAL DISPLAY PANEL

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