Potassium Citrate
These highlights do not include all the information needed to use POTASSIUM CITRATE EXTEND-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE extended-release tablets, for oral useInitial U.S. Approval: 1985
Approved
Approval ID
4af19ffc-80e1-4182-bccf-e7abb1bf457c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code63629-8759
Application NumberANDA209758
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Citrate
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2022
FDA Product Classification
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