Potassium Citrate

Product NDC
44523-415
11-digit product format
445230415
Labeler code
44523
Product ID
44523-415_461546fa-70f8-dad0-e063-6394a90a4675
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
potassium citrate
Dosage form
TABLET
Route
ORAL
Labeler
Biocomp Pharma, Inc.
Application
NDA019071
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-12-23
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 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
N019071-001UROCIT-KPOTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALABRLD1985-08-30
N019071-002UROCIT-KPOTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALABRLD1992-08-31
N019071-003UROCIT-KPOTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019071-001AB
N019071-002AB
N019071-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019071-001UROCIT-K5MEQTABLET, EXTENDED RELEASE / ORALABRLD1985-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019071-002UROCIT-K10MEQTABLET, EXTENDED RELEASE / ORALABRLD1992-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019071-003UROCIT-K15MEQTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-12-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019071-001UROCIT-K5MEQTABLET, EXTENDED RELEASE / ORALABRLD1985-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019071-002UROCIT-K10MEQTABLET, EXTENDED RELEASE / ORALABRLD1992-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019071-003UROCIT-K15MEQTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-12-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N019071-001UROCIT-K5MEQTABLET, EXTENDED RELEASE / ORALABRLD1985-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019071-002UROCIT-K10MEQTABLET, EXTENDED RELEASE / ORALABRLD1992-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019071-003UROCIT-K15MEQTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-12-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019071-001UROCIT-K5MEQTABLET, EXTENDED RELEASE / ORALABRLD1985-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019071-002UROCIT-K10MEQTABLET, EXTENDED RELEASE / ORALABRLD1992-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019071-003UROCIT-K15MEQTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-12-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019071-001UROCIT-K5MEQTABLET, EXTENDED RELEASE / ORALABRLD1985-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019071-002UROCIT-K10MEQTABLET, EXTENDED RELEASE / ORALABRLD1992-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019071-003UROCIT-K15MEQTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-12-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019071-001UROCIT-K5MEQTABLET, EXTENDED RELEASE / ORALABRLD1985-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019071-002UROCIT-K10MEQTABLET, EXTENDED RELEASE / ORALABRLD1992-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019071-003UROCIT-K15MEQTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-12-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019071-001UROCIT-K5MEQTABLET, EXTENDED RELEASE / ORALABRLD1985-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019071-002UROCIT-K10MEQTABLET, EXTENDED RELEASE / ORALABRLD1992-08-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019071-003UROCIT-K15MEQTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-12-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019071-001UROCIT-K5MEQTABLET, EXTENDED RELEASE / ORALABRLD1985-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019071-002UROCIT-K10MEQTABLET, EXTENDED RELEASE / ORALABRLD1992-08-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019071-003UROCIT-K15MEQTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-12-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019071-001UROCIT-K5MEQTABLET, EXTENDED RELEASE / ORALABRLD1985-08-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019071-002UROCIT-K10MEQTABLET, EXTENDED RELEASE / ORALABRLD1992-08-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019071-003UROCIT-K15MEQTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-12-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019071-001UROCIT-K5MEQTABLET, EXTENDED RELEASE / ORALABRLD1985-08-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N019071-002UROCIT-K10MEQTABLET, EXTENDED RELEASE / ORALABRLD1992-08-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N019071-003UROCIT-K15MEQTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-12-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019071-001UROCIT-K5MEQTABLET, EXTENDED RELEASE / ORALABRLD1985-08-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019071-002UROCIT-K10MEQTABLET, EXTENDED RELEASE / ORALABRLD1992-08-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019071-003UROCIT-K15MEQTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-12-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019071-001UROCIT-K5MEQTABLET, EXTENDED RELEASE / ORALABRLD1985-08-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019071-002UROCIT-K10MEQTABLET, EXTENDED RELEASE / ORALABRLD1992-08-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019071-003UROCIT-K15MEQTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-12-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019071-001UROCIT-K5MEQTABLET, EXTENDED RELEASE / ORALABRLD1985-08-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019071-002UROCIT-K10MEQTABLET, EXTENDED RELEASE / ORALABRLD1992-08-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019071-003UROCIT-K15MEQTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-12-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019071-001UROCIT-K5MEQTABLET, EXTENDED RELEASE / ORALABRLD1985-08-308072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N019071-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019071-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019071-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019071-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019071-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019071-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019071-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019071-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019071-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019071-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019071-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019071-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019071-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019071-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019071-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019071-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019071-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019071-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019071-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019071-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019071-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019071-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019071-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019071-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019071-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019071-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019071-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019071-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019071-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019071-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019071-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019071-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019071-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019071-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019071-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019071-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019071-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019071-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019071-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019071-001AB18072bd15b7f6…

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
b32fe71a-4a58-04a1-64d3-bc3cc4a895bfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44523-415-01Potassium Citrate100 in 1 BOTTLETABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-415-01EA - Each44523-415ba7f3221-9b46-46b3-adb1-35bdea3b445f12014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM CITRATEACTIVE INGREDIENTEE90ONI6FFPOTASSIUM CITRATE TABLET [BIOCOMP PHARMA, INC.]1
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLPOTASSIUM CITRATE TABLET [BIOCOMP PHARMA, INC.]1
Carnauba WaxINACTIVE INGREDIENTR12CBM0EIZPOTASSIUM CITRATE TABLET [BIOCOMP PHARMA, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30POTASSIUM CITRATE TABLET [BIOCOMP PHARMA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-415POTASSIUM CITRATE TABLET [BIOCOMP PHARMA, INC.]10Current NDC, Legacy NDC, 1 package rows20241207_b32fe71a-4a58-04a1-64d3-bc3cc4a895bf.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium CitratePOTASSIUM CITRATEBiocomp Pharma, Inc.b32fe71a-4a58-04a1-64d3-bc3cc4a895bf2025-12-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 019071
application number: NDA019071
ndc (product): 44523-415
Potassium CitratePOTASSIUM CITRATEUpsher-Smith Laboratories, LLC2215dc1d-0b5a-469e-9b51-4d7480a510782025-07-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 019071
application number: NDA019071
UROCIT-KPOTASSIUM CITRATEMission Pharmacal Company72cdea1b-2240-41db-987d-86d5c6aaa9782021-12-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 019071
application number: NDA019071

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199381potassium citrate 10 MEQ Extended Release Oral TabletPSNb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11
898490potassium citrate 15 MEQ Extended Release Oral TabletPSNb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11
199381potassium citrate 10 MEQ Extended Release Oral TabletSCDb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11
898490potassium citrate 15 MEQ Extended Release Oral TabletSCDb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11
199381K+ citrate 10 MEQ Extended Release Oral TabletSYb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11
898490K+ citrate 15 MEQ Extended Release Oral TabletSYb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11
199381Pot citrate 10 MEQ Extended Release Oral TabletSYb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11
898490Pot citrate 15 MEQ Extended Release Oral TabletSYb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11
199381potassium citrate 1080 MG Extended Release Oral TabletSYb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11
898490potassium citrate 1620 MG Extended Release Oral TabletSYb32fe71a-4a58-04a1-64d3-bc3cc4a895bf11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44523-415-0144523041501100 TABLET in 1 BOTTLE (44523-415-01) 100 tablet2013-12-230000-00-00NoNoCurrent