Potassium chloride extended release
These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP. Potassium chloride extended-release tablets, USP for oral useInitial U.S. Approval: 1948
Approved
Approval ID
10d71ce7-ecb0-458d-b987-b9abd97cbab4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2022
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
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 Code71205-996
Application NumberANDA205993
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium chloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2022
FDA Product Classification
INGREDIENTS (11)
POTASSIUM CHLORIDEActive
Quantity: 750 mg in 1 1
Code: 660YQ98I10
Classification: ACTIB
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT