POTASSIUM CHLORIDE
These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES Initial U.S. Approval: 1948
Approved
Approval ID
be92d952-f8e1-4930-978a-9d1765de6a27
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 17, 2021
Manufacturers
FDA
Zydus Pharmaceuticals (USA) Inc.
DUNS: 156861945
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 Code68382-702
Application NumberNDA018238
Product Classification
M
Marketing Category
C73605
G
Generic Name
potassium chloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 17, 2021
FDA Product Classification
INGREDIENTS (10)
POTASSIUM CHLORIDEActive
Quantity: 600 mg in 1 1
Code: 660YQ98I10
Classification: ACTIB
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
potassium chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-701
Application NumberNDA018238
Product Classification
M
Marketing Category
C73605
G
Generic Name
potassium chloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 17, 2021
FDA Product Classification
INGREDIENTS (10)
POTASSIUM CHLORIDEActive
Quantity: 750 mg in 1 1
Code: 660YQ98I10
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT