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 useInitial U.S. Approval: 1985
Approved
Approval ID
9774b7c5-4695-47c9-9eb8-e0af2e05f5c3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2022
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 Code71335-1706
Application NumberANDA206813
Product Classification
M
Marketing Category
C73584
G
Generic Name
POTASSIUM CITRATE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 25, 2022
FDA Product Classification
INGREDIENTS (4)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
POTASSIUM CITRATEActive
Quantity: 10 meq in 1 1
Code: EE90ONI6FF
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT