FDA.reportPublic FDA data

Potassium Citrate

Product NDC
62559-291
11-digit product format
625590291
Labeler code
62559
Product ID
62559-291_ce0ee9e0-f0bc-4578-b4cd-d3d353171e82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
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, 898490

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
62559-291-01Potassium Citrate100 in 1 BOTTLETABLET, EXTENDED RELEASE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-291-01EA - Each62559-291c4fceb2f-9397-4cb9-b1b2-847f27b4efaa12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-291POTASSIUM CITRATE TABLET, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 1 package rows20220108_2fb31727-68b1-4183-947d-00e08bf99987.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
199381potassium citrate 10 MEQ Extended Release Oral TabletPSNff67f638-5b53-406a-962a-87773a91fc48104
199381potassium citrate 10 MEQ Extended Release Oral TabletSCDff67f638-5b53-406a-962a-87773a91fc48104
199381K+ citrate 10 MEQ Extended Release Oral TabletSYff67f638-5b53-406a-962a-87773a91fc48104
199381Pot citrate 10 MEQ Extended Release Oral TabletSYff67f638-5b53-406a-962a-87773a91fc48104
199381potassium citrate 1080 MG Extended Release Oral TabletSYff67f638-5b53-406a-962a-87773a91fc48104
199381potassium citrate 10 MEQ Extended Release Oral TabletPSN595343aa-b760-4158-9c49-dd5368f45e2c101
199381potassium citrate 10 MEQ Extended Release Oral TabletSCD595343aa-b760-4158-9c49-dd5368f45e2c101
199381K+ citrate 10 MEQ Extended Release Oral TabletSY595343aa-b760-4158-9c49-dd5368f45e2c101
199381Pot citrate 10 MEQ Extended Release Oral TabletSY595343aa-b760-4158-9c49-dd5368f45e2c101
199381potassium citrate 1080 MG Extended Release Oral TabletSY595343aa-b760-4158-9c49-dd5368f45e2c101
199381potassium citrate 10 MEQ Extended Release Oral TabletPSN2fb31727-68b1-4183-947d-00e08bf999876
199381potassium citrate 10 MEQ Extended Release Oral TabletPSNa9cc636d-3e26-450c-9df8-665d530d626f6
898490potassium citrate 15 MEQ Extended Release Oral TabletPSN2fb31727-68b1-4183-947d-00e08bf999876
199381potassium citrate 10 MEQ Extended Release Oral TabletSCDa9cc636d-3e26-450c-9df8-665d530d626f6
199381potassium citrate 10 MEQ Extended Release Oral TabletSCD2fb31727-68b1-4183-947d-00e08bf999876
898490potassium citrate 15 MEQ Extended Release Oral TabletSCD2fb31727-68b1-4183-947d-00e08bf999876
199381K+ citrate 10 MEQ Extended Release Oral TabletSYa9cc636d-3e26-450c-9df8-665d530d626f6
199381K+ citrate 10 MEQ Extended Release Oral TabletSY2fb31727-68b1-4183-947d-00e08bf999876
898490K+ citrate 15 MEQ Extended Release Oral TabletSY2fb31727-68b1-4183-947d-00e08bf999876
199381Pot citrate 10 MEQ Extended Release Oral TabletSYa9cc636d-3e26-450c-9df8-665d530d626f6
199381Pot citrate 10 MEQ Extended Release Oral TabletSY2fb31727-68b1-4183-947d-00e08bf999876
898490Pot citrate 15 MEQ Extended Release Oral TabletSY2fb31727-68b1-4183-947d-00e08bf999876
199381potassium citrate 1080 MG Extended Release Oral TabletSYa9cc636d-3e26-450c-9df8-665d530d626f6
199381potassium citrate 1080 MG Extended Release Oral TabletSY2fb31727-68b1-4183-947d-00e08bf999876
898490potassium citrate 1620 MG Extended Release Oral TabletSY2fb31727-68b1-4183-947d-00e08bf999876

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62559-291-0162559029101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62559-291-01) 2020-03-160000-00-00NoNoCurrent