FDA.reportPublic FDA data

Potassium Citrate

Product NDC
70518-3160
11-digit product format
705183160
Labeler code
70518
Product ID
70518-3160_4ec9e26c-9caf-0355-e063-6294a90ac9e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA212779
Marketing category
ANDA
Marketing start
2021-07-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Potassium Citrate
Listing expiration
2027-12-31

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
70518-3160-0Potassium Citrate100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3160POTASSIUM CITRATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 1 package rows20240315_a9cc636d-3e26-450c-9df8-665d530d626f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199381potassium citrate 10 MEQ Extended Release Oral TabletPSNa9cc636d-3e26-450c-9df8-665d530d626f6
199381potassium citrate 10 MEQ Extended Release Oral TabletSCDa9cc636d-3e26-450c-9df8-665d530d626f6
199381K+ citrate 10 MEQ Extended Release Oral TabletSYa9cc636d-3e26-450c-9df8-665d530d626f6
199381Pot citrate 10 MEQ Extended Release Oral TabletSYa9cc636d-3e26-450c-9df8-665d530d626f6
199381potassium citrate 1080 MG Extended Release Oral TabletSYa9cc636d-3e26-450c-9df8-665d530d626f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3160-070518316000100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3160-0) 2021-07-150000-00-00NoNoCurrent