FDA.reportPublic FDA data

Potassium Citrate

Product NDC
0245-0071
11-digit product format
002450071
Labeler code
0245
Product ID
0245-0071_39e81850-ac5b-656e-e063-6294a90a1d94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
potassium citrate
Dosage form
TABLET
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
NDA019071
Marketing category
NDA
Marketing start
2006-09-01
Marketing end
2027-07-31
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

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
0245-0071-11Potassium Citrate100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0245-0071-11EA - Each0245-007159f5be8f-2539-494c-a516-55302749cd3b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
potassium citrateACTIVE INGREDIENTEE90ONI6FFPOTASSIUM CITRATE TABLET [UPSHER-SMITH LABORATORIES, INC.]3
anhydrous citric acidACTIVE MOIETYXF417D3PSLPOTASSIUM CITRATE TABLET [UPSHER-SMITH LABORATORIES, INC.]3
carnauba waxINACTIVE INGREDIENTR12CBM0EIZPOTASSIUM CITRATE TABLET [UPSHER-SMITH LABORATORIES, INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30POTASSIUM CITRATE TABLET [UPSHER-SMITH LABORATORIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0245-0071POTASSIUM CITRATE TABLET [UPSHER-SMITH LABORATORIES, LLC]6Current NDC, Legacy NDC, 1 package rows20220812_2215dc1d-0b5a-469e-9b51-4d7480a51078.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199381potassium citrate 10 MEQ Extended Release Oral TabletPSN2215dc1d-0b5a-469e-9b51-4d7480a510787
199376potassium citrate 5 MEQ Extended Release Oral TabletPSN2215dc1d-0b5a-469e-9b51-4d7480a510787
199381potassium citrate 10 MEQ Extended Release Oral TabletSCD2215dc1d-0b5a-469e-9b51-4d7480a510787
199376potassium citrate 5 MEQ Extended Release Oral TabletSCD2215dc1d-0b5a-469e-9b51-4d7480a510787
199381K+ citrate 10 MEQ Extended Release Oral TabletSY2215dc1d-0b5a-469e-9b51-4d7480a510787
199376K+ citrate 5 MEQ Extended Release Oral TabletSY2215dc1d-0b5a-469e-9b51-4d7480a510787
199381Pot citrate 10 MEQ Extended Release Oral TabletSY2215dc1d-0b5a-469e-9b51-4d7480a510787
199376Pot citrate 5 MEQ Extended Release Oral TabletSY2215dc1d-0b5a-469e-9b51-4d7480a510787
199381potassium citrate 1080 MG Extended Release Oral TabletSY2215dc1d-0b5a-469e-9b51-4d7480a510787
199376potassium citrate 540 MG Extended Release Oral TabletSY2215dc1d-0b5a-469e-9b51-4d7480a510787

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0245-0071-1100245007111100 TABLET in 1 BOTTLE (0245-0071-11) 100 tablet2006-09-012027-07-31NoNoCurrent