Potassium Citrate

Product NDC
65841-538
11-digit product format
658410538
Labeler code
65841
Product ID
65841-538_042721ed-7f5d-47f1-beff-b54ba88bcd27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA203546
Marketing category
ANDA
Marketing start
2014-08-12
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203546-001POTASSIUM CITRATEPOTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06
A203546-002POTASSIUM CITRATEPOTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06
A203546-003POTASSIUM CITRATEPOTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203546-001AB
A203546-002AB
A203546-003AB

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 06:07:402026-07A203546-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06caaa826d4ba7…
2026-08-18 06:07:402026-07A203546-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06caaa826d4ba7…
2026-08-18 06:07:402026-07A203546-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203546-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203546-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203546-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203546-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203546-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203546-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A203546-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203546-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203546-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203546-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203546-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203546-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203546-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203546-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203546-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203546-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203546-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203546-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203546-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203546-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203546-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203546-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203546-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203546-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203546-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203546-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203546-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203546-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A203546-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A203546-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203546-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203546-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203546-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203546-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203546-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203546-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203546-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2014-08-061e350fbaab3a…

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 06:07:402026-07A203546-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203546-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203546-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203546-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203546-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203546-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203546-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203546-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203546-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203546-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203546-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203546-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203546-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203546-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203546-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203546-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203546-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203546-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203546-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203546-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203546-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203546-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203546-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203546-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203546-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203546-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203546-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203546-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203546-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203546-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203546-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203546-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203546-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203546-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203546-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203546-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203546-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203546-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203546-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203546-001AB11e350fbaab3a…

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 · 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
39f46084-fc4b-4bfc-91cb-9be7e647655aAvailable 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
65841-538-01Potassium Citrate100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
65841-538-05Potassium Citrate500 in 1 BOTTLETABLET, EXTENDED RELEASE5005
65841-538-06Potassium Citrate30 in 1 BOTTLETABLET, EXTENDED RELEASE305
65841-538-10Potassium Citrate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10005
65841-538-16Potassium Citrate90 in 1 BOTTLETABLET, EXTENDED RELEASE905
65841-538-30Potassium Citrate10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE105
65841-538-30Potassium Citrate10 in 1 CARTONTABLET, EXTENDED RELEASE105

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM CITRATEACTIVE INGREDIENTEE90ONI6FFPOTASSIUM CITRATE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLPOTASSIUM CITRATE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPOTASSIUM CITRATE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30POTASSIUM CITRATE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-538POTASSIUM CITRATE TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 7 package rows20231004_39f46084-fc4b-4bfc-91cb-9be7e647655a.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium CitratePOTASSIUM CITRATEAmerican Health Packaging1201c777-2388-4235-bb8f-eb7dc1e867f82024-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203546
application number: ANDA203546
Potassium CitratePOTASSIUM CITRATEGolden State Medical Supply, Inc.cb09c63d-f3f0-5d6b-e053-2995a90acd442023-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203546
application number: ANDA203546
Potassium CitratePOTASSIUM CITRATEZydus Lifesciences Limited39f46084-fc4b-4bfc-91cb-9be7e647655a2023-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203546
application number: ANDA203546
ndc (product): 65841-538
Potassium CitratePOTASSIUM CITRATEZydus Pharmaceuticals (USA) Inc.1a839f91-9bbd-4f46-b350-c5e8074b5db72023-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203546
application number: ANDA203546

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199381potassium citrate 10 MEQ Extended Release Oral TabletPSN39f46084-fc4b-4bfc-91cb-9be7e647655a5
898490potassium citrate 15 MEQ Extended Release Oral TabletPSN39f46084-fc4b-4bfc-91cb-9be7e647655a5
199376potassium citrate 5 MEQ Extended Release Oral TabletPSN39f46084-fc4b-4bfc-91cb-9be7e647655a5
199381potassium citrate 10 MEQ Extended Release Oral TabletSCD39f46084-fc4b-4bfc-91cb-9be7e647655a5
898490potassium citrate 15 MEQ Extended Release Oral TabletSCD39f46084-fc4b-4bfc-91cb-9be7e647655a5
199376potassium citrate 5 MEQ Extended Release Oral TabletSCD39f46084-fc4b-4bfc-91cb-9be7e647655a5
199381K+ citrate 10 MEQ Extended Release Oral TabletSY39f46084-fc4b-4bfc-91cb-9be7e647655a5
898490K+ citrate 15 MEQ Extended Release Oral TabletSY39f46084-fc4b-4bfc-91cb-9be7e647655a5
199376K+ citrate 5 MEQ Extended Release Oral TabletSY39f46084-fc4b-4bfc-91cb-9be7e647655a5
199381Pot citrate 10 MEQ Extended Release Oral TabletSY39f46084-fc4b-4bfc-91cb-9be7e647655a5
898490Pot citrate 15 MEQ Extended Release Oral TabletSY39f46084-fc4b-4bfc-91cb-9be7e647655a5
199376Pot citrate 5 MEQ Extended Release Oral TabletSY39f46084-fc4b-4bfc-91cb-9be7e647655a5
199381potassium citrate 1080 MG Extended Release Oral TabletSY39f46084-fc4b-4bfc-91cb-9be7e647655a5
898490potassium citrate 1620 MG Extended Release Oral TabletSY39f46084-fc4b-4bfc-91cb-9be7e647655a5
199376potassium citrate 540 MG Extended Release Oral TabletSY39f46084-fc4b-4bfc-91cb-9be7e647655a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-538-0165841053801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-538-01) 2014-08-120000-00-00NoNoCurrent
65841-538-0565841053805500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-538-05) 2014-08-120000-00-00NoNoCurrent
65841-538-066584105380630 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-538-06) 2014-08-120000-00-00NoNoCurrent
65841-538-10658410538101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-538-10) 2014-08-120000-00-00NoNoCurrent
65841-538-166584105381690 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-538-16) 2014-08-120000-00-00NoNoCurrent
65841-538-306584105383010 BLISTER PACK in 1 CARTON (65841-538-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2014-08-120000-00-00NoNoCurrent