Potassium Citrate
POTASSIUM CITRATE 5 and 10 mEq Extended Release Tablets for Oral Use These highlights do not include all the information needed to use Potassium Citrate safely and effectively. See full prescribing information for Potassium Citrate. Initial U.S. Approval: 1985
Approved
Approval ID
2215dc1d-0b5a-469e-9b51-4d7480a51078
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 11, 2022
Manufacturers
FDA
Upsher-Smith Laboratories, LLC
DUNS: 079111820
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
potassium citrate
PRODUCT DETAILS
NDC Product Code0245-0071
Application NumberNDA019071
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 11, 2022
Generic Namepotassium citrate
INGREDIENTS (3)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM CITRATEActive
Quantity: 10 meq in 1 1
Code: EE90ONI6FF
Classification: ACTIB
potassium citrate
PRODUCT DETAILS
NDC Product Code0245-0070
Application NumberNDA019071
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 11, 2022
Generic Namepotassium citrate
INGREDIENTS (3)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
POTASSIUM CITRATEActive
Quantity: 5 meq in 1 1
Code: EE90ONI6FF
Classification: ACTIB