FDA.reportPublic FDA data

Potassium Citrate

Product NDC
63629-1967
11-digit product format
636291967
Labeler code
63629
Product ID
63629-1967_72a84600-76b3-4803-ad0d-737680420295
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212779
Marketing category
ANDA
Marketing start
2020-03-16
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
Rxcui898490

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1967-1Potassium Citrate100 in 1 BOTTLETABLET, EXTENDED RELEASE100106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1967-1EA - Each63629-196761b2551c-cb92-47ae-9271-7b78487ff44012021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1967POTASSIUM CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 1 package rows20240807_f2ab3c2e-2a6e-4698-afad-260bdf0d259e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898490potassium citrate 15 MEQ Extended Release Oral TabletPSNf2ab3c2e-2a6e-4698-afad-260bdf0d259e106
898490potassium citrate 15 MEQ Extended Release Oral TabletSCDf2ab3c2e-2a6e-4698-afad-260bdf0d259e106
898490K+ citrate 15 MEQ Extended Release Oral TabletSYf2ab3c2e-2a6e-4698-afad-260bdf0d259e106
898490Pot citrate 15 MEQ Extended Release Oral TabletSYf2ab3c2e-2a6e-4698-afad-260bdf0d259e106
898490potassium citrate 1620 MG Extended Release Oral TabletSYf2ab3c2e-2a6e-4698-afad-260bdf0d259e106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1967-163629196701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1967-1) 2022-02-080000-00-00NoNoCurrent