Potassium Citrate
These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE extended-release tablets for oral use Initial U.S. Approval: 1985
Approved
Approval ID
1201c777-2388-4235-bb8f-eb7dc1e867f8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2022
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Potassium Citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68084-850
Application NumberANDA203546
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Citrate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2022
FDA Product Classification
INGREDIENTS (3)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
POTASSIUM CITRATEActive
Quantity: 10 meq in 1 1
Code: EE90ONI6FF
Classification: ACTIB