potassium chloride
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1948
Approved
Approval ID
52d91d76-8c7f-40f1-9f5c-e05962cabedd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2021
Manufacturers
FDA
Solco Healthcare LLC
DUNS: 828343017
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 Code43547-552
Application NumberANDA209026
Product Classification
M
Marketing Category
C73584
G
Generic Name
potassium chloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2019
FDA Product Classification
INGREDIENTS (9)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POTASSIUM CHLORIDEActive
Quantity: 600 mg in 1 1
Code: 660YQ98I10
Classification: ACTIB
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
potassium chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43547-553
Application NumberANDA209026
Product Classification
M
Marketing Category
C73584
G
Generic Name
potassium chloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2019
FDA Product Classification
INGREDIENTS (11)
POTASSIUM CHLORIDEActive
Quantity: 750 mg in 1 1
Code: 660YQ98I10
Classification: ACTIB
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT