FDA.reportPublic FDA data

POTASSIUM CITRATE

Product NDC
72162-2478
11-digit product format
721622478
Labeler code
72162
Product ID
72162-2478_54d422f4-91ce-443a-b14a-5fc09fbe4b6d
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
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
Brand name suffix
EXTENDED RELEASE
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
72162-2478-1POTASSIUM CITRATEEXTENDED RELEASE100 in 1 BOTTLETABLET100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2478-1EA - Each72162-2478799b29b0-82a1-4595-a91b-d8b067230b8012025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2478POTASSIUM CITRATE EXTENDED RELEASE (POTASSIUM CITRATE) TABLET [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20250504_8f5f7078-3c2d-406f-9222-b82a0f79d168.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898490potassium citrate 15 MEQ Extended Release Oral TabletPSN8f5f7078-3c2d-406f-9222-b82a0f79d168102
898490potassium citrate 15 MEQ Extended Release Oral TabletSCD8f5f7078-3c2d-406f-9222-b82a0f79d168102
898490K+ citrate 15 MEQ Extended Release Oral TabletSY8f5f7078-3c2d-406f-9222-b82a0f79d168102
898490Pot citrate 15 MEQ Extended Release Oral TabletSY8f5f7078-3c2d-406f-9222-b82a0f79d168102
898490potassium citrate 1620 MG Extended Release Oral TabletSY8f5f7078-3c2d-406f-9222-b82a0f79d168102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2478-172162247801100 TABLET in 1 BOTTLE (72162-2478-1) 100 tablet2025-05-01NoNoHistorical