Potassium Chloride
These highlights do not include all the information needed to use potassium chloride extended-release tablets safely and effectively. See full prescribing information for potassium chloride extended-release tablets. Potassium chloride extended-release tablets, for oral use Initial U.S. Approval: 1948
Approved
Approval ID
8d140d5e-a5d7-5302-3572-e606dd247410
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2018
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc
DUNS: 156861945
Products 4
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 Code68382-398
Application NumberNDA018279
Product Classification
M
Marketing Category
C73605
G
Generic Name
Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (10)
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
VANILLINInactive
Code: CHI530446X
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
POTASSIUM CHLORIDEActive
Quantity: 1500 mg in 1 1
Code: 660YQ98I10
Classification: ACTIB
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
POLYVINYL ACETATEInactive
Code: 32K497ZK2U
Classification: IACT
Potassium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-776
Application NumberNDA018279
Product Classification
M
Marketing Category
C73605
G
Generic Name
Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (11)
POTASSIUM CHLORIDEActive
Quantity: 600 mg in 1 1
Code: 660YQ98I10
Classification: ACTIB
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
VANILLINInactive
Code: CHI530446X
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ACETATEInactive
Code: 32K497ZK2U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
Potassium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-320
Application NumberNDA018279
Product Classification
M
Marketing Category
C73605
G
Generic Name
Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (11)
POTASSIUM CHLORIDEActive
Quantity: 750 mg in 1 1
Code: 660YQ98I10
Classification: ACTIB
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
VANILLINInactive
Code: CHI530446X
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
POLYVINYL ACETATEInactive
Code: 32K497ZK2U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
Potassium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-600
Application NumberNDA018279
Product Classification
M
Marketing Category
C73605
G
Generic Name
Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (11)
POTASSIUM CHLORIDEActive
Quantity: 750 mg in 1 1
Code: 660YQ98I10
Classification: ACTIB
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
VANILLINInactive
Code: CHI530446X
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
POLYVINYL ACETATEInactive
Code: 32K497ZK2U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT