Potassium Chloride
Potassium Chloride Extended-Release Tablets, USP MICRO-DISPERSIBLE TECHNOLOGY
Approved
Approval ID
ad584ce4-a64d-4851-80e9-0eeedc0b9d06
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 31, 2023
Manufacturers
FDA
Upsher-SmithLaboratories, LLC
DUNS: 047251004
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 Code0832-5324
Application NumberANDA074726
Product Classification
M
Marketing Category
C73584
G
Generic Name
potassium chloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2022
FDA Product Classification
INGREDIENTS (4)
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
potassium chlorideActive
Quantity: 750 mg in 1 1
Code: 660YQ98I10
Classification: ACTIB
ethylcellulose (20 MPA.S)Inactive
Code: BJG0S321QY
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
potassium chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0832-5325
Application NumberANDA074726
Product Classification
M
Marketing Category
C73584
G
Generic Name
potassium chloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2022
FDA Product Classification
INGREDIENTS (4)
potassium chlorideActive
Quantity: 1500 mg in 1 1
Code: 660YQ98I10
Classification: ACTIB
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
ethylcellulose (20 MPA.S)Inactive
Code: BJG0S321QY
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT