FDA.reportPublic FDA data

POTASSIUM CITRATE

Product NDC
72865-191
11-digit product format
728650191
Labeler code
72865
Product ID
72865-191_7809b770-e255-4e34-b38f-90a0d51eeaea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc.
Application
ANDA214420
Marketing category
ANDA
Marketing start
2021-02-25
Substance
POTASSIUM CITRATE
Active strength
5 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 CITRATE5 meq/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEE90ONI6FF
Rxcui199376, 199381, 898490

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72865-191-01POTASSIUM CITRATE100 in 1 BOTTLETABLET, EXTENDED RELEASE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-191-01EA - Each72865-1913787f4ea-7449-4dea-8ebe-413b8cdbddda12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-191POTASSIUM CITRATE TABLET, EXTENDED RELEASE [XLCARE PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 1 package rows20220127_360a1012-4bdb-473a-8f1f-4550d3b51343.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199381potassium citrate 10 MEQ Extended Release Oral TabletPSN360a1012-4bdb-473a-8f1f-4550d3b513432
898490potassium citrate 15 MEQ Extended Release Oral TabletPSN360a1012-4bdb-473a-8f1f-4550d3b513432
199376potassium citrate 5 MEQ Extended Release Oral TabletPSN360a1012-4bdb-473a-8f1f-4550d3b513432
199381potassium citrate 10 MEQ Extended Release Oral TabletSCD360a1012-4bdb-473a-8f1f-4550d3b513432
898490potassium citrate 15 MEQ Extended Release Oral TabletSCD360a1012-4bdb-473a-8f1f-4550d3b513432
199376potassium citrate 5 MEQ Extended Release Oral TabletSCD360a1012-4bdb-473a-8f1f-4550d3b513432
199381K+ citrate 10 MEQ Extended Release Oral TabletSY360a1012-4bdb-473a-8f1f-4550d3b513432
898490K+ citrate 15 MEQ Extended Release Oral TabletSY360a1012-4bdb-473a-8f1f-4550d3b513432
199376K+ citrate 5 MEQ Extended Release Oral TabletSY360a1012-4bdb-473a-8f1f-4550d3b513432
199381Pot citrate 10 MEQ Extended Release Oral TabletSY360a1012-4bdb-473a-8f1f-4550d3b513432
898490Pot citrate 15 MEQ Extended Release Oral TabletSY360a1012-4bdb-473a-8f1f-4550d3b513432
199376Pot citrate 5 MEQ Extended Release Oral TabletSY360a1012-4bdb-473a-8f1f-4550d3b513432
199381potassium citrate 1080 MG Extended Release Oral TabletSY360a1012-4bdb-473a-8f1f-4550d3b513432
898490potassium citrate 1620 MG Extended Release Oral TabletSY360a1012-4bdb-473a-8f1f-4550d3b513432
199376potassium citrate 540 MG Extended Release Oral TabletSY360a1012-4bdb-473a-8f1f-4550d3b513432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72865-191-0172865019101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72865-191-01) 2021-02-250000-00-00NoNoCurrent