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
1a839f91-9bbd-4f46-b350-c5e8074b5db7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 3, 2023
Manufacturers
FDA
Zydus Pharmaceuticals (USA) Inc.
DUNS: 156861945
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 Code68382-537
Application NumberANDA203546
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 3, 2023
Generic NamePotassium Citrate
INGREDIENTS (3)
POTASSIUM CITRATEActive
Quantity: 10 meq in 1 1
Code: EE90ONI6FF
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Potassium Citrate
PRODUCT DETAILS
NDC Product Code68382-538
Application NumberANDA203546
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 3, 2023
Generic NamePotassium Citrate
INGREDIENTS (3)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
POTASSIUM CITRATEActive
Quantity: 15 meq in 1 1
Code: EE90ONI6FF
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Potassium Citrate
PRODUCT DETAILS
NDC Product Code68382-536
Application NumberANDA203546
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 3, 2023
Generic NamePotassium Citrate
INGREDIENTS (3)
POTASSIUM CITRATEActive
Quantity: 5 meq in 1 1
Code: EE90ONI6FF
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT