FDA.reportPublic FDA data

Potassium Citrate

Product NDC
44523-415
11-digit product format
445230415
Labeler code
44523
Product ID
44523-415_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
2013-12-23
Substance
POTASSIUM CITRATE
Active strength
15 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

Additional Listing Data#

Finished product
Yes
Brand name base
Potassium Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CITRATE15 meq/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEE90ONI6FF
Rxcui199381, 898490

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44523-415-012024-02-27C16284748780-19d75b9d0-6457-f424-e053-dadaa90a57cePOTASSIUM CITRATE Extended-Release Tablets for Oral Use These highlights do not include all the information needed to use Potassium Citrate safely and effectively. See full prescribing information for Potassium Citrate. Initial U.S. Approval: 1985
44523-415-012024-01-30C16284748780-19d75b9d0-6457-f424-e053-dadaa90a57cePOTASSIUM CITRATE Extended-Release Tablets for Oral Use These highlights do not include all the information needed to use Potassium Citrate safely and effectively. See full prescribing information for Potassium Citrate. Initial U.S. Approval: 1985
44523-415-012020-04-28C16284748780-19d75b9d0-6457-f424-e053-dadaa90a57cePOTASSIUM CITRATE Extended-Release Tablets for Oral Use These highlights do not include all the information needed to use Potassium Citrate safely and effectively. See full prescribing information for Potassium Citrate. Initial U.S. Approval: 1985
44523-415-012020-01-31C16284748780-19d75b9d0-6457-f424-e053-dadaa90a57cePOTASSIUM CITRATE Extended-Release Tablets for Oral Use These highlights do not include all the information needed to use Potassium Citrate safely and effectively. See full prescribing information for Potassium Citrate. Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44523-415-01Potassium Citrate100 in 1 BOTTLETABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-415-01EA - Each44523-415ba7f3221-9b46-46b3-adb1-35bdea3b445f12014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM CITRATEACTIVE INGREDIENTEE90ONI6FFPOTASSIUM CITRATE TABLET [BIOCOMP PHARMA, INC.]1
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLPOTASSIUM CITRATE TABLET [BIOCOMP PHARMA, INC.]1
Carnauba WaxINACTIVE INGREDIENTR12CBM0EIZPOTASSIUM CITRATE TABLET [BIOCOMP PHARMA, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30POTASSIUM CITRATE TABLET [BIOCOMP PHARMA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-415POTASSIUM CITRATE TABLET [BIOCOMP PHARMA, INC.]10Current NDC, Legacy NDC, 1 package rows20241207_b32fe71a-4a58-04a1-64d3-bc3cc4a895bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199381potassium citrate 10 MEQ Extended Release Oral TabletPSNb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11
898490potassium citrate 15 MEQ Extended Release Oral TabletPSNb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11
199381potassium citrate 10 MEQ Extended Release Oral TabletSCDb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11
898490potassium citrate 15 MEQ Extended Release Oral TabletSCDb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11
199381K+ citrate 10 MEQ Extended Release Oral TabletSYb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11
898490K+ citrate 15 MEQ Extended Release Oral TabletSYb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11
199381Pot citrate 10 MEQ Extended Release Oral TabletSYb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11
898490Pot citrate 15 MEQ Extended Release Oral TabletSYb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11
199381potassium citrate 1080 MG Extended Release Oral TabletSYb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11
898490potassium citrate 1620 MG Extended Release Oral TabletSYb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44523-415-0144523041501100 TABLET in 1 BOTTLE (44523-415-01) 100 tablet2013-12-230000-00-00NoNoCurrent