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
3d460e84-27a0-485c-8b11-58d03d9064aa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 28, 2021
Manufacturers
FDA
Guardian Drug Company
DUNS: 119210276
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 Code53041-681
Application NumberANDA214892
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2023
FDA Product Classification
INGREDIENTS (10)
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
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
Potassium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53041-680
Application NumberANDA214892
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2023
FDA Product Classification
INGREDIENTS (10)
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
POTASSIUM CHLORIDEActive
Quantity: 40 meq in 15 mL
Code: 660YQ98I10
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT