FDA.reportPublic FDA data

Potassium-cit

Product NDC
71930-048
11-digit product format
719300048
Labeler code
71930
Product ID
71930-048_c3b1a90a-ad23-430f-a10d-782f28740caf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium-cit
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Eywa Pharma Inc
Application
ANDA214426
Marketing category
ANDA
Marketing start
2021-03-01
Marketing end
0000-00-00
Substance
POTASSIUM CITRATE
Active strength
5 meq/1
Pharmacologic classes
Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
71930-048-122024-01-30C16284748780-11030e365-2aec-111a-e063-dadaa90a10e2These 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71930-048-12Potassium-cit100 in 1 BOTTLETABLET, EXTENDED RELEASE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71930-048-12EA - Each71930-0482521a78b-2490-4706-bbed-e740139fe66812021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71930-048POTASSIUM-CIT TABLET, EXTENDED RELEASE POTASSIUM-CIT TABLET, EXTENDED RELEASE [EYWA PHARMA INC]4Legacy NDC, 1 package rows20220111_5ccd4d38-0dcd-4bf7-96fd-a263ff468e1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199381potassium citrate 10 MEQ Extended Release Oral TabletPSN5ccd4d38-0dcd-4bf7-96fd-a263ff468e1a4
898490potassium citrate 15 MEQ Extended Release Oral TabletPSN5ccd4d38-0dcd-4bf7-96fd-a263ff468e1a4
199376potassium citrate 5 MEQ Extended Release Oral TabletPSN5ccd4d38-0dcd-4bf7-96fd-a263ff468e1a4
199381potassium citrate 10 MEQ Extended Release Oral TabletSCD5ccd4d38-0dcd-4bf7-96fd-a263ff468e1a4
898490potassium citrate 15 MEQ Extended Release Oral TabletSCD5ccd4d38-0dcd-4bf7-96fd-a263ff468e1a4
199376potassium citrate 5 MEQ Extended Release Oral TabletSCD5ccd4d38-0dcd-4bf7-96fd-a263ff468e1a4
199381K+ citrate 10 MEQ Extended Release Oral TabletSY5ccd4d38-0dcd-4bf7-96fd-a263ff468e1a4
898490K+ citrate 15 MEQ Extended Release Oral TabletSY5ccd4d38-0dcd-4bf7-96fd-a263ff468e1a4
199376K+ citrate 5 MEQ Extended Release Oral TabletSY5ccd4d38-0dcd-4bf7-96fd-a263ff468e1a4
199381Pot citrate 10 MEQ Extended Release Oral TabletSY5ccd4d38-0dcd-4bf7-96fd-a263ff468e1a4
898490Pot citrate 15 MEQ Extended Release Oral TabletSY5ccd4d38-0dcd-4bf7-96fd-a263ff468e1a4
199376Pot citrate 5 MEQ Extended Release Oral TabletSY5ccd4d38-0dcd-4bf7-96fd-a263ff468e1a4
199381potassium citrate 1080 MG Extended Release Oral TabletSY5ccd4d38-0dcd-4bf7-96fd-a263ff468e1a4
898490potassium citrate 1620 MG Extended Release Oral TabletSY5ccd4d38-0dcd-4bf7-96fd-a263ff468e1a4
199376potassium citrate 540 MG Extended Release Oral TabletSY5ccd4d38-0dcd-4bf7-96fd-a263ff468e1a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71930-048-1271930004812100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71930-048-12) 2021-03-010000-00-00NoNoCurrent