NDC Code(s) : 0245-0042-11, 0245-0042-15, 0245-0042-10, 0245-0042-55, 0245-0042-00, 0245-0043-11, 0245-0043-15, 0245-0043-10, 0245-0043-55, 0245-0043-00
Packager : Upsher-Smith Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Potassium ChloridePotassium Chloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0245-0042
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 Chloride600 mg
Inactive Ingredients
Ingredient Name Strength
hydrogenated cottonseed oil(UNII: Z82Y2C65EA)
magnesium stearate(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
silicon dioxide(UNII: ETJ7Z6XBU4)
talc(UNII: 7SEV7J4R1U)
titanium dioxide(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color BLUE (dark blue) Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code USL;8
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0245-0042-11100 in 1 BOTTLE Type 0: Not a Combination Product17/04/1986
2NDC:0245-0042-15500 in 1 BOTTLE Type 0: Not a Combination Product17/04/1986
3NDC:0245-0042-101000 in 1 BOTTLE Type 0: Not a Combination Product17/04/1986
4NDC:0245-0042-551 in 1 BOX 17/04/1986
45000 in 1 BAG Type 0: Not a Combination Product17/04/1986
5NDC:0245-0042-001 in 1 BOX 17/04/1986
510000 in 1 BAG Type 0: Not a Combination Product17/04/1986
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019123 04/17/1986 04/30/2005
Potassium ChloridePotassium Chloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0245-0043
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
hydrogenated cottonseed oil(UNII: Z82Y2C65EA)
magnesium stearate(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
silicon dioxide(UNII: ETJ7Z6XBU4)
talc(UNII: 7SEV7J4R1U)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 13 mm
Flavor Imprint Code USL;10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0245-0043-11100 in 1 BOTTLE Type 0: Not a Combination Product17/04/1986
2NDC:0245-0043-15500 in 1 BOTTLE Type 0: Not a Combination Product17/04/1986
3NDC:0245-0043-101000 in 1 BOTTLE Type 0: Not a Combination Product17/04/1986
4NDC:0245-0043-551 in 1 BOX 17/04/1986
45000 in 1 BAG Type 0: Not a Combination Product17/04/1986
5NDC:0245-0043-001 in 1 BOX 17/04/1986
510000 in 1 BAG Type 0: Not a Combination Product17/04/1986
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019123 04/17/1986 04/30/2005

PRINCIPAL DISPLAY PANEL

NDC 0245-0242-10
1000 Tablets

Potassium Chloride
Extended-release
Tablets, USP

8 mEq (600 mg)

Rx only

UPSHER-SMITH

PRINCIPAL DISPLAY PANEL - 600 mg/1000 Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0245-0243-10
1000 Tablets

Potassium Chloride
Extended-release
Tablets, USP

10 mEq (750 mg)

Rx only

UPSHER-SMITH

PRINCIPAL DISPLAY PANEL - 750 mg/1000 Tablet Bottle Label