NDC Code(s) : 27808-067-01, 27808-066-01
Packager : Tris Pharma 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:27808-067
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
(CHLORIDE ION - UNII:Q32ZN48698) 		POTASSIUM CHLORIDE8 meq
Inactive Ingredients
Ingredient Name Strength
AMMONIA(UNII: 5138Q19F1X)
COCONUT OIL(UNII: Q9L0O73W7L)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
GELATIN(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
OLEIC ACID(UNII: 2UMI9U37CP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code Trisoncap;067onbody
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:27808-067-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/07/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201944 07/01/2016 11/29/2016
Potassium ChloridePotassium Chloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27808-066
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
(CHLORIDE ION - UNII:Q32ZN48698) 		POTASSIUM CHLORIDE10 meq
Inactive Ingredients
Ingredient Name Strength
AMMONIA(UNII: 5138Q19F1X)
COCONUT OIL(UNII: Q9L0O73W7L)
GELATIN(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
OLEIC ACID(UNII: 2UMI9U37CP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
WATER(UNII: 059QF0KO0R)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color BLUE (Light Blue-opaque) Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code Trisoncap;066onbody
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:27808-066-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/07/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201944 07/01/2016 11/29/2016

PRINCIPAL DISPLAY PANEL

Label (600 mg) 8 mEq K   Bottles of 100

34732894-figure-01

Label (750 mg) 10 mEq K   Bottles of 100

34732894-figure-01