MedPath

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

NDC Product Code72322-1031
Application NumberANDA214395
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 5, 2021
Generic Namepotassium chloride

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

NDC Product Code72322-1032
Application NumberANDA214395
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 5, 2021
Generic Namepotassium chloride

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
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Potassium Chloride - FDA Approval | MedPath