Potassium Citrate

Product NDC
62559-292
11-digit product format
625590292
Labeler code
62559
Product ID
62559-292_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
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212779-001POTASSIUM CITRATEPOTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14
A212779-002POTASSIUM CITRATEPOTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A212779-001AB
A212779-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14caaa826d4ba7…
2026-08-18 06:07:402026-07A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-144b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212779-001POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14782e0a99824c…
2021-12-28 21:50 UTC2021-12A212779-002POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2020-01-14782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A212779-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212779-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212779-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212779-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212779-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212779-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212779-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212779-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212779-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212779-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212779-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212779-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212779-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212779-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212779-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212779-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212779-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212779-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212779-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212779-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212779-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212779-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212779-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212779-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212779-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212779-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212779-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212779-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212779-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212779-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212779-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212779-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212779-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212779-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212779-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212779-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212779-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212779-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212779-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A212779-002AB1782e0a99824c…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EE90ONI6FFInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199381Internal RxNorm lookup
898490Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2fb31727-68b1-4183-947d-00e08bf99987Available on FDA.report

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
62559-292-01Potassium Citrate100 in 1 BOTTLETABLET, EXTENDED RELEASE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-292-01EA - Each62559-29217e32b92-1ed5-4347-a32d-0914843c5acd12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-292POTASSIUM CITRATE TABLET, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 1 package rows20220108_2fb31727-68b1-4183-947d-00e08bf99987.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium CitratePOTASSIUM CITRATEBryant Ranch Prepackff67f638-5b53-406a-962a-87773a91fc482026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212779
application number: ANDA212779
Potassium CitratePOTASSIUM CITRATEREMEDYREPACK INC.a9cc636d-3e26-450c-9df8-665d530d626f2026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212779
application number: ANDA212779
Potassium CitratePOTASSIUM CITRATEBryant Ranch Prepack6271d84e-d991-4bb8-ac9f-6d5cc879b6312026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212779
application number: ANDA212779
Potassium CitratePOTASSIUM CITRATEBryant Ranch Prepack595343aa-b760-4158-9c49-dd5368f45e2c2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212779
application number: ANDA212779
Potassium CitratePOTASSIUM CITRATEANI Pharmaceuticals, Inc.2fb31727-68b1-4183-947d-00e08bf999872025-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212779
application number: ANDA212779
ndc (product): 62559-292
Potassium CitratePOTASSIUM CITRATEBryant Ranch Prepackebf1f1f1-4458-4d34-8432-21698a550e072025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212779
application number: ANDA212779
Potassium CitratePOTASSIUM CITRATEBryant Ranch Prepackf2ab3c2e-2a6e-4698-afad-260bdf0d259e2024-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212779
application number: ANDA212779

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898490potassium citrate 15 MEQ Extended Release Oral TabletPSNf2ab3c2e-2a6e-4698-afad-260bdf0d259e106
898490potassium citrate 15 MEQ Extended Release Oral TabletSCDf2ab3c2e-2a6e-4698-afad-260bdf0d259e106
898490K+ citrate 15 MEQ Extended Release Oral TabletSYf2ab3c2e-2a6e-4698-afad-260bdf0d259e106
898490Pot citrate 15 MEQ Extended Release Oral TabletSYf2ab3c2e-2a6e-4698-afad-260bdf0d259e106
898490potassium citrate 1620 MG Extended Release Oral TabletSYf2ab3c2e-2a6e-4698-afad-260bdf0d259e106
898490potassium citrate 15 MEQ Extended Release Oral TabletPSN6271d84e-d991-4bb8-ac9f-6d5cc879b631101
898490potassium citrate 15 MEQ Extended Release Oral TabletSCD6271d84e-d991-4bb8-ac9f-6d5cc879b631101
898490K+ citrate 15 MEQ Extended Release Oral TabletSY6271d84e-d991-4bb8-ac9f-6d5cc879b631101
898490Pot citrate 15 MEQ Extended Release Oral TabletSY6271d84e-d991-4bb8-ac9f-6d5cc879b631101
898490potassium citrate 1620 MG Extended Release Oral TabletSY6271d84e-d991-4bb8-ac9f-6d5cc879b631101
199381potassium citrate 10 MEQ Extended Release Oral TabletPSN2fb31727-68b1-4183-947d-00e08bf999876
898490potassium citrate 15 MEQ Extended Release Oral TabletPSN2fb31727-68b1-4183-947d-00e08bf999876
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 TabletSY2fb31727-68b1-4183-947d-00e08bf999876
898490K+ citrate 15 MEQ Extended Release Oral TabletSY2fb31727-68b1-4183-947d-00e08bf999876
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 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
62559-292-0162559029201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62559-292-01) 2020-03-160000-00-00NoNoCurrent