UROCIT-K

Product NDC
0178-0600
11-digit product format
001780600
Labeler code
0178
Product ID
0178-0600_efcc3822-015a-770b-e053-2995a90ab933
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
potassium citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Mission Pharmacal Company
Application
NDA019071
Marketing category
NDA
Marketing start
1985-09-01
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0178-0600DDiscontinued by firm2026-08-07
excluded packagepackage0178-06000178-0600-01DDiscontinued by firm2026-08-07

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct0178-0600DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0178-06000178-0600-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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…

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
0178-0600-01UROCIT-K100 in 1 BOTTLETABLET, EXTENDED RELEASE10028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0600-01EA - Each0178-0600eb6709c7-dee0-4c53-8732-650fa4d5d62812012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0600UROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [MISSION PHARMACAL COMPANY]26Legacy NDC, 1 package rows20240529_72cdea1b-2240-41db-987d-86d5c6aaa978.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
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
ndc (product): 0178-0600

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199381potassium citrate 10 MEQ Extended Release Oral TabletPSN72cdea1b-2240-41db-987d-86d5c6aaa97828
898490potassium citrate 15 MEQ Extended Release Oral TabletPSN72cdea1b-2240-41db-987d-86d5c6aaa97828
199376potassium citrate 5 MEQ Extended Release Oral TabletPSN72cdea1b-2240-41db-987d-86d5c6aaa97828
603281UROCIT-K 10 MEQ Extended Release Oral TabletPSN72cdea1b-2240-41db-987d-86d5c6aaa97828
898517UROCIT-K 15 MEQ Extended Release Oral TabletPSN72cdea1b-2240-41db-987d-86d5c6aaa97828
603282UROCIT-K 5 MEQ Extended Release Oral TabletPSN72cdea1b-2240-41db-987d-86d5c6aaa97828
603281potassium citrate 10 MEQ Extended Release Oral Tablet [Urocit-K]SBD72cdea1b-2240-41db-987d-86d5c6aaa97828
898517potassium citrate 15 MEQ Extended Release Oral Tablet [Urocit-K]SBD72cdea1b-2240-41db-987d-86d5c6aaa97828
603282potassium citrate 5 MEQ Extended Release Oral Tablet [Urocit-K]SBD72cdea1b-2240-41db-987d-86d5c6aaa97828
199381potassium citrate 10 MEQ Extended Release Oral TabletSCD72cdea1b-2240-41db-987d-86d5c6aaa97828
898490potassium citrate 15 MEQ Extended Release Oral TabletSCD72cdea1b-2240-41db-987d-86d5c6aaa97828
199376potassium citrate 5 MEQ Extended Release Oral TabletSCD72cdea1b-2240-41db-987d-86d5c6aaa97828
199381K+ citrate 10 MEQ Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
603281K+ citrate 10 MEQ Extended Release Oral Tablet [Urocit-K]SY72cdea1b-2240-41db-987d-86d5c6aaa97828
898490K+ citrate 15 MEQ Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
898517K+ citrate 15 MEQ Extended Release Oral Tablet [Urocit-K]SY72cdea1b-2240-41db-987d-86d5c6aaa97828
199376K+ citrate 5 MEQ Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
603282K+ citrate 5 MEQ Extended Release Oral Tablet [Urocit-K]SY72cdea1b-2240-41db-987d-86d5c6aaa97828
199381Pot citrate 10 MEQ Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
603281Pot citrate 10 MEQ Extended Release Oral Tablet [Urocit-K]SY72cdea1b-2240-41db-987d-86d5c6aaa97828
898490Pot citrate 15 MEQ Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
898517Pot citrate 15 MEQ Extended Release Oral Tablet [Urocit-K]SY72cdea1b-2240-41db-987d-86d5c6aaa97828
199376Pot citrate 5 MEQ Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
603282Pot citrate 5 MEQ Extended Release Oral Tablet [Urocit-K]SY72cdea1b-2240-41db-987d-86d5c6aaa97828
199381potassium citrate 1080 MG Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
898490potassium citrate 1620 MG Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
199376potassium citrate 540 MG Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
603281Urocit-K 10 MEQ Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
898517Urocit-K 15 MEQ Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
898517Urocit-K 1620 MG Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
603282Urocit-K 5 MEQ Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0178-0600-0100178060001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0178-0600-01) 2009-12-300000-00-00NoNoCurrent