FDA.reportPublic FDA data

POTASSIUM CITRATE

Product NDC
71335-1706
11-digit product format
713351706
Labeler code
71335
Product ID
71335-1706_8212127c-30d8-41f6-9f2b-ddeed4c6ad1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POTASSIUM CITRATE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206813
Marketing category
ANDA
Marketing start
2017-11-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
POTASSIUM CITRATE
Brand name suffix
EXTENDED RELEASE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CITRATE10 meq/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEE90ONI6FF
Rxcui199381

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1706-12024-05-21C16284748780-11030e365-51d4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-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
71335-1706-12024-01-30C16284748780-11030e365-51d4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-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
71335-1706-1POTASSIUM CITRATEEXTENDED RELEASE30 in 1 BOTTLETABLET30103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1706POTASSIUM CITRATE EXTENDED RELEASE (POTASSIUM CITRATE) TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240522_9774b7c5-4695-47c9-9eb8-e0af2e05f5c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199381potassium citrate 10 MEQ Extended Release Oral TabletPSN9774b7c5-4695-47c9-9eb8-e0af2e05f5c3103
199381potassium citrate 10 MEQ Extended Release Oral TabletSCD9774b7c5-4695-47c9-9eb8-e0af2e05f5c3103
199381K+ citrate 10 MEQ Extended Release Oral TabletSY9774b7c5-4695-47c9-9eb8-e0af2e05f5c3103
199381Pot citrate 10 MEQ Extended Release Oral TabletSY9774b7c5-4695-47c9-9eb8-e0af2e05f5c3103
199381potassium citrate 1080 MG Extended Release Oral TabletSY9774b7c5-4695-47c9-9eb8-e0af2e05f5c3103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1706-17133517060130 TABLET in 1 BOTTLE (71335-1706-1) 30 tablet2020-09-100000-00-00NoNoCurrent