FDA.reportPublic FDA data

POTASSIUM CITRATE

Product NDC
72162-2476
11-digit product format
721622476
Labeler code
72162
Product ID
72162-2476_5ce2f57e-a740-4806-9605-c339b82af8d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POTASSIUM CITRATE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206813
Marketing category
ANDA
Marketing start
2017-11-01
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
Brand name suffix
EXTENDED RELEASE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CITRATE5 meq/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEE90ONI6FF
Rxcui199376

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
72162-2476-1POTASSIUM CITRATEEXTENDED RELEASE100 in 1 BOTTLETABLET100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2476-1EA - Each72162-2476915ce705-3983-4cc4-b8c9-0e0c8d0b701912025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2476POTASSIUM CITRATE EXTENDED RELEASE (POTASSIUM CITRATE) TABLET [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20250504_44ab2c4f-4a76-470d-98fb-8874c692a967.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199376potassium citrate 5 MEQ Extended Release Oral TabletPSN44ab2c4f-4a76-470d-98fb-8874c692a967102
199376potassium citrate 5 MEQ Extended Release Oral TabletSCD44ab2c4f-4a76-470d-98fb-8874c692a967102
199376K+ citrate 5 MEQ Extended Release Oral TabletSY44ab2c4f-4a76-470d-98fb-8874c692a967102
199376Pot citrate 5 MEQ Extended Release Oral TabletSY44ab2c4f-4a76-470d-98fb-8874c692a967102
199376potassium citrate 540 MG Extended Release Oral TabletSY44ab2c4f-4a76-470d-98fb-8874c692a967102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2476-172162247601100 TABLET in 1 BOTTLE (72162-2476-1) 100 tablet2025-05-01NoNoHistorical