Potassium Chloride (Page 3 of 3)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Potassium Chloride Extended-Release Capsules USP

600 mg (8 mEq K) – Bottle of 100s

NDC 68180-798-01 Bottles of 100s

Potassium Chloride Extended-Release Capsules USP
600 mg (8 mEq K)
							NDC 68180-798-01 -- Bottle of 100s
(click image for full-size original)

Potassium Chloride Extended-Release Capsules USP

750 mg (10 mEq K) – Bottle of 100s

NDC 68180-799-01 Bottles of 100s

Potassium Chloride Extended-Release Capsules USP
750 mg (10 mEq K)
							NDC 68180-799-01 -- Bottle of 100s
(click image for full-size original)
POTASSIUM CHLORIDE
potassium chloride capsule, coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-799
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 10 meq
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE (10 MPA.S)
ETHYLCELLULOSE (45 MPA.S)
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color BLUE (Opaque Blue) Score no score
Shape CAPSULE Size 26mm
Flavor Imprint Code LU;R52
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-799-01 100 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:57297-799-02 500 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:57297-799-03 1000 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203002 01/18/2016
POTASSIUM CHLORIDE
potassium chloride capsule, coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-798
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 8 meq
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE (10 MPA.S)
ETHYLCELLULOSE (45 MPA.S)
FERROSOFERRIC OXIDE
GELATIN
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color WHITE (Opaque White) Score no score
Shape CAPSULE Size 24mm
Flavor Imprint Code LU;R51
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-798-01 100 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:57297-798-02 500 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203002 01/18/2016
Labeler — LUPIN LIMITED (675923163)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 863645527 manufacture (57297-798), manufacture (57297-799), pack (57297-798), pack (57297-799)

Revised: 05/2016 LUPIN LIMITED

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