POTASSIUM CITRATE

Product NDC
42543-408
11-digit product format
425430408
Labeler code
42543
Product ID
42543-408_e9e76355-cc27-427b-a787-7628a4b88eb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POTASSIUM CITRATE
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Inc.
Application
ANDA206813
Marketing category
ANDA
Marketing start
2017-11-01
Substance
POTASSIUM CITRATE
Active strength
15 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
Brand name suffix
EXTENDED RELEASE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CITRATE15 meq/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEE90ONI6FF
Rxcui199376, 199381, 898490

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
42543-408-01POTASSIUM CITRATEEXTENDED RELEASE100 in 1 BOTTLETABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42543-408-01EA - Each42543-4088b535d7b-f913-4baa-b914-893058893a2512017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42543-408POTASSIUM CITRATE EXTENDED RELEASE (POTASSIUM CITRATE) TABLET [STRIDES PHARMA INC.]9Current NDC, Legacy NDC, 1 package rows20230622_5f38b02c-703c-4fc2-b833-654e41bd617f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898490potassium citrate 15 MEQ Extended Release Oral TabletPSN8f5f7078-3c2d-406f-9222-b82a0f79d168102
898490potassium citrate 15 MEQ Extended Release Oral TabletSCD8f5f7078-3c2d-406f-9222-b82a0f79d168102
898490K+ citrate 15 MEQ Extended Release Oral TabletSY8f5f7078-3c2d-406f-9222-b82a0f79d168102
898490Pot citrate 15 MEQ Extended Release Oral TabletSY8f5f7078-3c2d-406f-9222-b82a0f79d168102
898490potassium citrate 1620 MG Extended Release Oral TabletSY8f5f7078-3c2d-406f-9222-b82a0f79d168102
199381potassium citrate 10 MEQ Extended Release Oral TabletPSN5f38b02c-703c-4fc2-b833-654e41bd617f10
898490potassium citrate 15 MEQ Extended Release Oral TabletPSN5f38b02c-703c-4fc2-b833-654e41bd617f10
199376potassium citrate 5 MEQ Extended Release Oral TabletPSN5f38b02c-703c-4fc2-b833-654e41bd617f10
199381potassium citrate 10 MEQ Extended Release Oral TabletSCD5f38b02c-703c-4fc2-b833-654e41bd617f10
898490potassium citrate 15 MEQ Extended Release Oral TabletSCD5f38b02c-703c-4fc2-b833-654e41bd617f10
199376potassium citrate 5 MEQ Extended Release Oral TabletSCD5f38b02c-703c-4fc2-b833-654e41bd617f10
199381K+ citrate 10 MEQ Extended Release Oral TabletSY5f38b02c-703c-4fc2-b833-654e41bd617f10
898490K+ citrate 15 MEQ Extended Release Oral TabletSY5f38b02c-703c-4fc2-b833-654e41bd617f10
199376K+ citrate 5 MEQ Extended Release Oral TabletSY5f38b02c-703c-4fc2-b833-654e41bd617f10
199381Pot citrate 10 MEQ Extended Release Oral TabletSY5f38b02c-703c-4fc2-b833-654e41bd617f10
898490Pot citrate 15 MEQ Extended Release Oral TabletSY5f38b02c-703c-4fc2-b833-654e41bd617f10
199376Pot citrate 5 MEQ Extended Release Oral TabletSY5f38b02c-703c-4fc2-b833-654e41bd617f10
199381potassium citrate 1080 MG Extended Release Oral TabletSY5f38b02c-703c-4fc2-b833-654e41bd617f10
898490potassium citrate 1620 MG Extended Release Oral TabletSY5f38b02c-703c-4fc2-b833-654e41bd617f10
199376potassium citrate 540 MG Extended Release Oral TabletSY5f38b02c-703c-4fc2-b833-654e41bd617f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42543-408-0142543040801100 TABLET in 1 BOTTLE (42543-408-01) 100 tablet2017-11-010000-00-00NoNoCurrent