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 TABLETSPOTASSIUM CHLORIDE EXTENDED-RELEASE tablets, for oral useInitial U.S. Approval: 1948
Approved
Approval ID
a230185f-5493-487d-892a-5219869b4e47
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 9, 2025
Manufacturers
FDA
Upsher-Smith Laboratories, LLC
DUNS: 047251004
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 Code24979-229
Application NumberANDA218979
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 9, 2025
FDA Product Classification
INGREDIENTS (10)
Potassium ChlorideActive
Quantity: 600 mg in 1 1
Code: 660YQ98I10
Classification: ACTIM
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Potassium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24979-230
Application NumberANDA218979
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 9, 2025
FDA Product Classification
INGREDIENTS (12)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
Potassium ChlorideActive
Quantity: 750 mg in 1 1
Code: 660YQ98I10
Classification: ACTIM
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT