FDA.reportPublic FDA data

Potassium Citrate

Product NDC
51407-451
11-digit product format
514070451
Labeler code
51407
Product ID
51407-451_090bceb1-3052-f6af-e063-6394a90a7219
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA203546
Marketing category
ANDA
Marketing start
2014-08-06
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
Rxcui199376, 199381, 898490

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
51407-451-01Potassium Citrate100 in 1 BOTTLETABLET, EXTENDED RELEASE1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-451POTASSIUM CITRATE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]5Current NDC, Legacy NDC, 1 package rows20231108_cb09c63d-f3f0-5d6b-e053-2995a90acd44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199381potassium citrate 10 MEQ Extended Release Oral TabletPSNcb09c63d-f3f0-5d6b-e053-2995a90acd445
898490potassium citrate 15 MEQ Extended Release Oral TabletPSNcb09c63d-f3f0-5d6b-e053-2995a90acd445
199376potassium citrate 5 MEQ Extended Release Oral TabletPSNcb09c63d-f3f0-5d6b-e053-2995a90acd445
199381potassium citrate 10 MEQ Extended Release Oral TabletSCDcb09c63d-f3f0-5d6b-e053-2995a90acd445
898490potassium citrate 15 MEQ Extended Release Oral TabletSCDcb09c63d-f3f0-5d6b-e053-2995a90acd445
199376potassium citrate 5 MEQ Extended Release Oral TabletSCDcb09c63d-f3f0-5d6b-e053-2995a90acd445
199381K+ citrate 10 MEQ Extended Release Oral TabletSYcb09c63d-f3f0-5d6b-e053-2995a90acd445
898490K+ citrate 15 MEQ Extended Release Oral TabletSYcb09c63d-f3f0-5d6b-e053-2995a90acd445
199376K+ citrate 5 MEQ Extended Release Oral TabletSYcb09c63d-f3f0-5d6b-e053-2995a90acd445
199381Pot citrate 10 MEQ Extended Release Oral TabletSYcb09c63d-f3f0-5d6b-e053-2995a90acd445
898490Pot citrate 15 MEQ Extended Release Oral TabletSYcb09c63d-f3f0-5d6b-e053-2995a90acd445
199376Pot citrate 5 MEQ Extended Release Oral TabletSYcb09c63d-f3f0-5d6b-e053-2995a90acd445
199381potassium citrate 1080 MG Extended Release Oral TabletSYcb09c63d-f3f0-5d6b-e053-2995a90acd445
898490potassium citrate 1620 MG Extended Release Oral TabletSYcb09c63d-f3f0-5d6b-e053-2995a90acd445
199376potassium citrate 540 MG Extended Release Oral TabletSYcb09c63d-f3f0-5d6b-e053-2995a90acd445

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-451-0151407045101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-451-01) 2021-08-230000-00-00NoNoCurrent