POTASSIUM CITRATE

Product NDC
72865-191
Requested package NDC
72865-191-01
11-digit product format
728650191
Labeler code
72865
Product ID
72865-191_7809b770-e255-4e34-b38f-90a0d51eeaea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc.
Application
ANDA214420
Marketing category
ANDA
Marketing start
2021-02-25
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A214420-001POTASSIUM CITRATEPOTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05
A214420-002POTASSIUM CITRATEPOTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05
A214420-003POTASSIUM CITRATEPOTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214420-001AB
A214420-002AB
A214420-003AB

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 3 · 105 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214420-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214420-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214420-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214420-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214420-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214420-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A214420-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214420-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214420-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214420-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214420-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214420-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214420-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214420-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214420-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214420-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214420-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214420-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214420-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214420-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214420-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214420-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214420-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214420-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214420-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214420-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214420-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214420-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A214420-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A214420-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214420-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214420-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214420-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214420-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214420-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214420-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214420-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214420-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214420-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214420-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-058072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214420-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214420-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214420-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214420-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214420-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214420-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214420-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214420-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214420-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214420-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214420-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214420-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214420-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214420-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214420-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214420-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214420-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214420-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214420-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214420-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214420-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214420-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214420-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214420-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214420-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214420-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214420-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214420-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214420-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214420-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214420-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214420-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214420-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214420-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214420-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214420-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214420-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214420-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214420-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214420-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
POTASSIUM CITRATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CITRATE5 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
360a1012-4bdb-473a-8f1f-4550d3b51343Available 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
72865-191-01POTASSIUM CITRATE100 in 1 BOTTLETABLET, EXTENDED RELEASE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-191-01EA - Each72865-1913787f4ea-7449-4dea-8ebe-413b8cdbddda12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-191POTASSIUM CITRATE TABLET, EXTENDED RELEASE [XLCARE PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 1 package rows20220127_360a1012-4bdb-473a-8f1f-4550d3b51343.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 Prepackb3ccba22-48cd-45f8-8c72-b80f34fe56be2025-10-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214420
application number: ANDA214420
POTASSIUM CITRATEPOTASSIUM CITRATEREMEDYREPACK INC.08c769d4-1dc0-4130-8f9c-cddace13a79b2025-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214420
application number: ANDA214420
POTASSIUM CITRATEPOTASSIUM CITRATEBryant Ranch Prepack012c925e-5874-472b-a675-00bf79f649802024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214420
application number: ANDA214420
POTASSIUM CITRATEPOTASSIUM CITRATEBryant Ranch Prepackb977c77b-c212-408e-adac-61736e5ed3622023-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214420
application number: ANDA214420
POTASSIUM CITRATEPOTASSIUM CITRATEBryant Ranch Prepackd2e6ef87-f5d7-409a-91ed-ff0a4763c3bd2023-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214420
application number: ANDA214420
POTASSIUM CITRATEPOTASSIUM CITRATEXLCare Pharmaceuticals, Inc.360a1012-4bdb-473a-8f1f-4550d3b513432022-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214420
application number: ANDA214420
ndc (package): 72865-191-01
ndc (product): 72865-191
ndc11 (package): 72865019101
POTASSIUM CITRATEPOTASSIUM CITRATECamber Pharmaceuticals, Incea933654-e8d2-4662-9a9a-4a6d79a9fb202022-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214420
application number: ANDA214420

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199381potassium citrate 10 MEQ Extended Release Oral TabletPSN360a1012-4bdb-473a-8f1f-4550d3b513432
898490potassium citrate 15 MEQ Extended Release Oral TabletPSN360a1012-4bdb-473a-8f1f-4550d3b513432
199376potassium citrate 5 MEQ Extended Release Oral TabletPSN360a1012-4bdb-473a-8f1f-4550d3b513432
199381potassium citrate 10 MEQ Extended Release Oral TabletSCD360a1012-4bdb-473a-8f1f-4550d3b513432
898490potassium citrate 15 MEQ Extended Release Oral TabletSCD360a1012-4bdb-473a-8f1f-4550d3b513432
199376potassium citrate 5 MEQ Extended Release Oral TabletSCD360a1012-4bdb-473a-8f1f-4550d3b513432
199381K+ citrate 10 MEQ Extended Release Oral TabletSY360a1012-4bdb-473a-8f1f-4550d3b513432
898490K+ citrate 15 MEQ Extended Release Oral TabletSY360a1012-4bdb-473a-8f1f-4550d3b513432
199376K+ citrate 5 MEQ Extended Release Oral TabletSY360a1012-4bdb-473a-8f1f-4550d3b513432
199381Pot citrate 10 MEQ Extended Release Oral TabletSY360a1012-4bdb-473a-8f1f-4550d3b513432
898490Pot citrate 15 MEQ Extended Release Oral TabletSY360a1012-4bdb-473a-8f1f-4550d3b513432
199376Pot citrate 5 MEQ Extended Release Oral TabletSY360a1012-4bdb-473a-8f1f-4550d3b513432
199381potassium citrate 1080 MG Extended Release Oral TabletSY360a1012-4bdb-473a-8f1f-4550d3b513432
898490potassium citrate 1620 MG Extended Release Oral TabletSY360a1012-4bdb-473a-8f1f-4550d3b513432
199376potassium citrate 540 MG Extended Release Oral TabletSY360a1012-4bdb-473a-8f1f-4550d3b513432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72865-191-0172865019101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72865-191-01) 2021-02-250000-00-00NoNoCurrent