Potassium Chloride
Potassium Chloride Extended-Release Tablets, USP
Approved
Approval ID
ebbece9e-b112-410b-8a6f-db087c42263c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 5, 2021
Manufacturers
FDA
AMTA LABS LIMITED
DUNS: 664424833
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 Code72322-1031
Application NumberANDA214395
Product Classification
M
Marketing Category
C73584
G
Generic Name
potassium chloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 5, 2021
FDA Product Classification
INGREDIENTS (9)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
POTASSIUM CHLORIDEActive
Quantity: 750 mg in 1 1
Code: 660YQ98I10
Classification: ACTIB
potassium chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72322-1032
Application NumberANDA214395
Product Classification
M
Marketing Category
C73584
G
Generic Name
potassium chloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 5, 2021
FDA Product Classification
INGREDIENTS (9)
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POTASSIUM CHLORIDEActive
Quantity: 1500 mg in 1 1
Code: 660YQ98I10
Classification: ACTIB
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT