FDA.reportPublic FDA data

LOKELMA

Product NDC
50090-6501
11-digit product format
500906501
Labeler code
50090
Product ID
50090-6501_5bb5ae7d-0be6-4ecc-bb31-4eedd2f724b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium zirconium cyclosilicate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA207078
Marketing category
NDA
Marketing start
2018-09-04
Substance
SODIUM ZIRCONIUM CYCLOSILICATE
Active strength
10 g/10g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM ZIRCONIUM CYCLOSILICATE10 g/10g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD652ZWF066
Rxcui2047642, 2053927

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5a8f09f-bf3b-4b64-a5a6-c14b92cb0dfcProduct name120230809

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6501-0LOKELMA30 in 1 BOXPOWDER, FOR SUSPENSION308
50090-6501-0LOKELMA10 g in 1 PACKETPOWDER, FOR SUSPENSION108
50090-6501-1LOKELMA3 in 1 BAGPOWDER, FOR SUSPENSION38
50090-6501-1LOKELMA10 g in 1 PACKETPOWDER, FOR SUSPENSION108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6501-0EA - Each50090-65014ad141e4-1b8e-49e6-825b-558ffdd4fa6e12023-07-06
50090-6501-1EA - Each50090-65012f1b6b8b-b9dd-4581-99b1-418bb5e00fdd12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6501LOKELMA (SODIUM ZIRCONIUM CYCLOSILICATE) POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]5Current NDC, 4 package rows20230613_8833d6e6-33ab-4ea9-b78f-3ec30a904ef8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2053927Lokelma 10 GM Powder for Oral SuspensionPSN8833d6e6-33ab-4ea9-b78f-3ec30a904ef88
2047642sodium zirconium cyclosilicate 10 GM Powder for Oral SuspensionPSN8833d6e6-33ab-4ea9-b78f-3ec30a904ef88
2053927sodium zirconium cyclosilicate 10000 MG Powder for Oral Suspension [Lokelma]SBD8833d6e6-33ab-4ea9-b78f-3ec30a904ef88
2047642sodium zirconium cyclosilicate 10000 MG Powder for Oral SuspensionSCD8833d6e6-33ab-4ea9-b78f-3ec30a904ef88
2053927Lokelma 10 GM Powder for Oral SuspensionSY8833d6e6-33ab-4ea9-b78f-3ec30a904ef88
2053927Lokelma 10000 MG Powder for Oral SuspensionSY8833d6e6-33ab-4ea9-b78f-3ec30a904ef88
2047642sodium zirconium cyclosilicate 10 GM Powder for Oral SuspensionSY8833d6e6-33ab-4ea9-b78f-3ec30a904ef88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6501-05009065010030 PACKET in 1 BOX (50090-6501-0) / 10 g in 1 PACKET30 packet2023-05-25NoNoCurrent
50090-6501-1500906501013 PACKET in 1 BAG (50090-6501-1) / 10 g in 1 PACKET3 packet2023-06-07NoNoCurrent