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
02707146-331f-4511-a187-0152fc8bca85
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2023
Manufacturers
FDA
TWi Pharmaceuticals, Inc.
DUNS: 658402052
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 Code24979-232
Application NumberANDA209688
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2023
FDA Product Classification
INGREDIENTS (10)
Potassium ChlorideActive
Quantity: 1500 mg in 1 1
Code: 660YQ98I10
Classification: ACTIB
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Potassium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24979-231
Application NumberANDA209688
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2023
FDA Product Classification
INGREDIENTS (12)
Potassium ChlorideActive
Quantity: 750 mg in 1 1
Code: 660YQ98I10
Classification: ACTIB
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT