FDA.reportPublic FDA data

Potassium Citrate

Product NDC
63629-7980
Requested package NDC
63629-7980-1
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-798063629-7980-1IInactivated by FDA2026-07-31

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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209758-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05a50c72e98297…
2026-08-01 22:54:322026-06A209758-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05a50c72e98297…
2026-08-01 22:54:322026-06A209758-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2018-03-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209758-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A209758-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A209758-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7980-12024-01-30C16284748780-11030e365-084d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use POTASSIUM CITRATE EXTEND-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE extended-release tablets, for oral use Initial U.S. Approval: 1985

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

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) 2019-04-020000-00-00NoNoCurrent