Potassium Citrate

Product NDC
63629-7980
11-digit product format
636297980
Labeler code
63629
Product ID
63629-7980_874f3351-050a-48ef-a307-d8a7395a5431
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209758
Marketing category
ANDA
Marketing start
2018-05-30
Marketing end
0000-00-00
Substance
POTASSIUM CITRATE
Active strength
10 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 productproduct63629-7980IInactivated by FDA2026-08-17
excluded packagepackage63629-798063629-7980-1IInactivated by FDA2026-08-17

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-7980-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-7980-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-7980-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-7980-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-7980-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-7980-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-7980-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-7980-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-7980-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-7980-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-7980-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-7980-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63629-7980-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-7980-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-7980-11332a3947898…d4bfe170f9cd…

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…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7980-1Potassium Citrate30 in 1 BOTTLETABLET, EXTENDED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7980POTASSIUM CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]3Legacy NDC, 1 package rows20220914_23eb16a8-8cea-467b-9c2c-c7743942d90e.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199381potassium citrate 10 MEQ Extended Release Oral TabletPSN23eb16a8-8cea-467b-9c2c-c7743942d90e3
199381potassium citrate 10 MEQ Extended Release Oral TabletSCD23eb16a8-8cea-467b-9c2c-c7743942d90e3
199381K+ citrate 10 MEQ Extended Release Oral TabletSY23eb16a8-8cea-467b-9c2c-c7743942d90e3
199381Pot citrate 10 MEQ Extended Release Oral TabletSY23eb16a8-8cea-467b-9c2c-c7743942d90e3
199381potassium citrate 1080 MG Extended Release Oral TabletSY23eb16a8-8cea-467b-9c2c-c7743942d90e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7980-16362979800130 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7980-1) 2019-04-080000-00-00NoNoCurrent