Potassium Chloride
These highlights do not include all the information needed to use POTASSIUM CHLORIDE safely and effectively. See full prescribing information for POTASSIUM CHLORIDE. POTASSIUM CHLORIDE oral solution Initial U.S. Approval: 1948
Approved
Approval ID
e5214432-3517-4a90-9412-036752bd1139
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2020
Manufacturers
FDA
Par Pharmaceutical
DUNS: 092733690
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Potassium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0603-1543
Application NumberNDA206814
Product Classification
M
Marketing Category
C73594
G
Generic Name
Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2020
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
Potassium ChlorideActive
Quantity: 40 meq in 15 mL
Code: 660YQ98I10
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Sodium BenzoateInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Potassium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0603-1542
Application NumberNDA206814
Product Classification
M
Marketing Category
C73594
G
Generic Name
Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2020
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
Potassium ChlorideActive
Quantity: 20 meq in 15 mL
Code: 660YQ98I10
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Sodium BenzoateInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
SucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT