FDA.reportPublic FDA data

Potassium Citrate

Product NDC
0591-2729
11-digit product format
005912729
Labeler code
0591
Product ID
0591-2729_309b143e-7142-4a21-859e-715ba61e82f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA209758
Marketing category
ANDA
Marketing start
2018-05-30
Marketing end
2027-01-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Potassium Citrate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CITRATE10 meq/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEE90ONI6FF
Rxcui199376, 199381, 898490

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-2729-01Potassium Citrate100 in 1 BOTTLETABLET, EXTENDED RELEASE10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2729-01EA - Each0591-2729b09402d9-0580-4b3b-a37f-24867019ed2b12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2729POTASSIUM CITRATE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]11Current NDC, Legacy NDC, 1 package rows20240229_ac173781-486b-461c-97ae-8b5c69e20792.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
199381potassium citrate 10 MEQ Extended Release Oral TabletPSNac173781-486b-461c-97ae-8b5c69e2079212
898490potassium citrate 15 MEQ Extended Release Oral TabletPSNac173781-486b-461c-97ae-8b5c69e2079212
199376potassium citrate 5 MEQ Extended Release Oral TabletPSNac173781-486b-461c-97ae-8b5c69e2079212
199381potassium citrate 10 MEQ Extended Release Oral TabletSCDac173781-486b-461c-97ae-8b5c69e2079212
898490potassium citrate 15 MEQ Extended Release Oral TabletSCDac173781-486b-461c-97ae-8b5c69e2079212
199376potassium citrate 5 MEQ Extended Release Oral TabletSCDac173781-486b-461c-97ae-8b5c69e2079212
199381K+ citrate 10 MEQ Extended Release Oral TabletSYac173781-486b-461c-97ae-8b5c69e2079212
898490K+ citrate 15 MEQ Extended Release Oral TabletSYac173781-486b-461c-97ae-8b5c69e2079212
199376K+ citrate 5 MEQ Extended Release Oral TabletSYac173781-486b-461c-97ae-8b5c69e2079212
199381Pot citrate 10 MEQ Extended Release Oral TabletSYac173781-486b-461c-97ae-8b5c69e2079212
898490Pot citrate 15 MEQ Extended Release Oral TabletSYac173781-486b-461c-97ae-8b5c69e2079212
199376Pot citrate 5 MEQ Extended Release Oral TabletSYac173781-486b-461c-97ae-8b5c69e2079212
199381potassium citrate 1080 MG Extended Release Oral TabletSYac173781-486b-461c-97ae-8b5c69e2079212
898490potassium citrate 1620 MG Extended Release Oral TabletSYac173781-486b-461c-97ae-8b5c69e2079212
199376potassium citrate 540 MG Extended Release Oral TabletSYac173781-486b-461c-97ae-8b5c69e2079212
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
0591-2729-00005912729003915 TABLET, EXTENDED RELEASE in 1 DRUM (0591-2729-00)30-MAY-18Current
0591-2729-0100591272901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0591-2729-01) 2018-05-302027-01-31NoNoCurrent
0591-2729-77005912729779396 TABLET, EXTENDED RELEASE in 1 CONTAINER (0591-2729-77)07-AUG-24Current