Potassium Citrate

Product NDC
44523-410
11-digit product format
445230410
Labeler code
44523
Product ID
44523-410_461546fa-70f8-dad0-e063-6394a90a4675
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
potassium citrate
Dosage form
TABLET
Route
ORAL
Labeler
Biocomp Pharma, Inc.
Application
NDA019071
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-12-03
Substance
POTASSIUM CITRATE
Active strength
10 meq/1
Pharmacologic classes
Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
EE90ONI6FFPOTASSIUM CITRATE6100-05-6POTASSIUM CITRATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
44523-410-0144523041001100 TABLET in 1 BOTTLE (44523-410-01) 100 tablet2024-12-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Potassium CitrateBiocomp Pharma, Inc. | Mission Pharmacal Company2025-12-16HUMAN PRESCRIPTION DRUG LABEL11