UROCIT-K
Urocit ®-K (Potassium Citrate) Extended Release Tablets for Oral Use These highlights do not include all the information needed to use Urocit -K safely and effectively. See full prescribing information for Urocit -K. Initial U.S. Approval: 1985
Approved
Approval ID
72cdea1b-2240-41db-987d-86d5c6aaa978
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2024
Manufacturers
FDA
Mission Pharmacal Company
DUNS: 008117095
Products 3
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 Code0178-0600
Application NumberNDA019071
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJanuary 8, 2024
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
potassium citrate
PRODUCT DETAILS
NDC Product Code0178-0610
Application NumberNDA019071
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJanuary 8, 2024
Generic Namepotassium citrate
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
potassium citrate
PRODUCT DETAILS
NDC Product Code0178-0615
Application NumberNDA019071
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJanuary 8, 2024
Generic Namepotassium citrate
INGREDIENTS (3)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM CITRATEActive
Quantity: 15 meq in 1 1
Code: EE90ONI6FF
Classification: ACTIB