Potassium Citrate

Product NDC
0591-2742
Requested package NDC
0591-2742-77
11-digit product format
005912742
Labeler code
0591
Product ID
0591-2742_309b143e-7142-4a21-859e-715ba61e82f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA209758
Marketing category
ANDA
Marketing start
2018-05-30
Marketing end
2027-02-28
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
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage0591-27420591-2742-77UNFINISHEDActive or certified unfinished drug listing2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209758-001POTASSIUM CITRATEPOTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05
A209758-002POTASSIUM CITRATEPOTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05
A209758-003POTASSIUM CITRATEPOTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A209758-001AB
A209758-002AB
A209758-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209758-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05caaa826d4ba7…
2026-08-18 06:07:402026-07A209758-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05caaa826d4ba7…
2026-08-18 06:07:402026-07A209758-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209758-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209758-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209758-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209758-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209758-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209758-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A209758-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209758-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209758-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209758-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209758-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209758-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209758-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209758-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209758-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209758-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209758-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209758-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209758-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209758-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209758-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209758-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209758-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209758-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209758-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209758-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209758-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209758-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A209758-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A209758-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209758-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209758-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209758-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209758-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209758-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209758-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209758-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-051e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209758-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209758-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209758-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209758-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209758-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209758-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209758-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209758-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209758-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209758-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209758-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209758-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209758-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209758-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209758-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209758-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209758-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209758-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209758-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209758-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209758-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209758-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209758-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209758-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209758-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209758-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209758-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209758-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209758-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209758-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209758-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209758-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209758-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209758-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209758-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209758-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209758-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209758-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209758-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209758-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Potassium Citrate

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199376Internal RxNorm lookup
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
ac173781-486b-461c-97ae-8b5c69e20792Available on FDA.report

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
0591-2742-01Potassium Citrate100 in 1 BOTTLETABLET, EXTENDED RELEASE10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2742-01EA - Each0591-27427f78c5ee-32c4-486d-ad4c-d8b7b122e03812018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2742POTASSIUM CITRATE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]11Current NDC, Legacy NDC, 1 package rows20240229_ac173781-486b-461c-97ae-8b5c69e20792.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium CitratePOTASSIUM CITRATEBryant Ranch Prepack4af19ffc-80e1-4182-bccf-e7abb1bf457c2024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209758
application number: ANDA209758
Potassium CitratePOTASSIUM CITRATEActavis Pharma, Inc.ac173781-486b-461c-97ae-8b5c69e207922022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209758
application number: ANDA209758
ndc (product): 0591-2742

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199381potassium citrate 10 MEQ Extended Release Oral TabletPSNac173781-486b-461c-97ae-8b5c69e2079212
898490potassium citrate 15 MEQ Extended Release Oral TabletPSNac173781-486b-461c-97ae-8b5c69e2079212
199376potassium citrate 5 MEQ Extended Release Oral TabletPSNac173781-486b-461c-97ae-8b5c69e2079212
199381potassium citrate 10 MEQ Extended Release Oral TabletSCDac173781-486b-461c-97ae-8b5c69e2079212
898490potassium citrate 15 MEQ Extended Release Oral TabletSCDac173781-486b-461c-97ae-8b5c69e2079212
199376potassium citrate 5 MEQ Extended Release Oral TabletSCDac173781-486b-461c-97ae-8b5c69e2079212
199381K+ citrate 10 MEQ Extended Release Oral TabletSYac173781-486b-461c-97ae-8b5c69e2079212
898490K+ citrate 15 MEQ Extended Release Oral TabletSYac173781-486b-461c-97ae-8b5c69e2079212
199376K+ citrate 5 MEQ Extended Release Oral TabletSYac173781-486b-461c-97ae-8b5c69e2079212
199381Pot citrate 10 MEQ Extended Release Oral TabletSYac173781-486b-461c-97ae-8b5c69e2079212
898490Pot citrate 15 MEQ Extended Release Oral TabletSYac173781-486b-461c-97ae-8b5c69e2079212
199376Pot citrate 5 MEQ Extended Release Oral TabletSYac173781-486b-461c-97ae-8b5c69e2079212
199381potassium citrate 1080 MG Extended Release Oral TabletSYac173781-486b-461c-97ae-8b5c69e2079212
898490potassium citrate 1620 MG Extended Release Oral TabletSYac173781-486b-461c-97ae-8b5c69e2079212
199376potassium citrate 540 MG Extended Release Oral TabletSYac173781-486b-461c-97ae-8b5c69e2079212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startStatus
0591-2742-77005912742776264 TABLET, EXTENDED RELEASE in 1 CONTAINER (0591-2742-77)07-AUG-24Current