FDA.reportPublic FDA data

Potassium Citrate

Product NDC
63629-8759
11-digit product format
636298759
Labeler code
63629
Product ID
63629-8759_3af62a61-a384-4f52-aa75-6419fea90b54
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8759-1Potassium Citrate100 in 1 BOTTLETABLET, EXTENDED RELEASE100104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8759-1EA - Each63629-8759c09e339c-3ecc-4c32-ac45-401542bd15d112021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8759POTASSIUM CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20240112_4af19ffc-80e1-4182-bccf-e7abb1bf457c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199381potassium citrate 10 MEQ Extended Release Oral TabletPSN4af19ffc-80e1-4182-bccf-e7abb1bf457c104
199381potassium citrate 10 MEQ Extended Release Oral TabletSCD4af19ffc-80e1-4182-bccf-e7abb1bf457c104
199381K+ citrate 10 MEQ Extended Release Oral TabletSY4af19ffc-80e1-4182-bccf-e7abb1bf457c104
199381Pot citrate 10 MEQ Extended Release Oral TabletSY4af19ffc-80e1-4182-bccf-e7abb1bf457c104
199381potassium citrate 1080 MG Extended Release Oral TabletSY4af19ffc-80e1-4182-bccf-e7abb1bf457c104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8759-163629875901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8759-1) 2022-08-250000-00-00NoNoCurrent