FDA.reportPublic FDA data

Potassium Citrate

Product NDC
63629-1966
11-digit product format
636291966
Labeler code
63629
Product ID
63629-1966_9b6284f1-1838-4fc0-8153-86189c6f89fa
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
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CITRATE10 meq/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEE90ONI6FF
Rxcui199381

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
63629-1966-1Potassium Citrate100 in 1 BOTTLETABLET, EXTENDED RELEASE100105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1966POTASSIUM CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20231109_ebf1f1f1-4458-4d34-8432-21698a550e07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199381potassium citrate 10 MEQ Extended Release Oral TabletPSNebf1f1f1-4458-4d34-8432-21698a550e07105
199381potassium citrate 10 MEQ Extended Release Oral TabletSCDebf1f1f1-4458-4d34-8432-21698a550e07105
199381K+ citrate 10 MEQ Extended Release Oral TabletSYebf1f1f1-4458-4d34-8432-21698a550e07105
199381Pot citrate 10 MEQ Extended Release Oral TabletSYebf1f1f1-4458-4d34-8432-21698a550e07105
199381potassium citrate 1080 MG Extended Release Oral TabletSYebf1f1f1-4458-4d34-8432-21698a550e07105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1966-163629196601100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1966-1) 2022-02-080000-00-00NoNoCurrent