FDA.reportPublic FDA data

LOKELMA

Product NDC
0310-1110
11-digit product format
003101110
Labeler code
0310
Product ID
0310-1110_e97b97a9-6ad1-4b47-a5be-fefd7be47c23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium zirconium cyclosilicate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LOKELMA
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD652ZWF066
Rxcui2047633, 2047639, 2047642, 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
0310-1110-01LOKELMA10 g in 1 PACKETPOWDER, FOR SUSPENSION1028
0310-1110-30LOKELMA30 in 1 BOXPOWDER, FOR SUSPENSION3028
0310-1110-39LOKELMA11 in 1 BOXPOWDER, FOR SUSPENSION1128
0310-1110-91LOKELMA10 g in 1 PACKETPOWDER, FOR SUSPENSION1028
0310-1110-93LOKELMA3 in 1 BOXPOWDER, FOR SUSPENSION328
0310-1110-94LOKELMA11 in 1 BOXPOWDER, FOR SUSPENSION1128
0310-1110-98LOKELMA30 in 1 BOXPOWDER, FOR SUSPENSION3028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-1110-01EA - Each0310-11105fc5445c-17d1-4c7c-ad80-106fa61cde7f12018-09-05
0310-1110-30EA - Each0310-1110ce05dd26-736f-46d9-90ec-a012ccb6ea3012018-09-05
0310-1110-39EA - Each0310-1110bf60586d-683d-439e-8a6f-5a8df3ae562412018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-1110LOKELMA (SODIUM ZIRCONIUM CYCLOSILICATE) POWDER, FOR SUSPENSION [ASTRAZENECA PHARMACEUTICALS LP]28Current NDC, Legacy NDC, 7 package rows20250213_90bf8e28-748d-4e4b-a19f-9cf483370eff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2053927Lokelma 10 GM Powder for Oral SuspensionPSN90bf8e28-748d-4e4b-a19f-9cf483370eff28
2047639LOKELMA 5 GM Powder for Oral SuspensionPSN90bf8e28-748d-4e4b-a19f-9cf483370eff28
2047642sodium zirconium cyclosilicate 10 GM Powder for Oral SuspensionPSN90bf8e28-748d-4e4b-a19f-9cf483370eff28
2047633sodium zirconium cyclosilicate 5 GM Powder for Oral SuspensionPSN90bf8e28-748d-4e4b-a19f-9cf483370eff28
2053927sodium zirconium cyclosilicate 10000 MG Powder for Oral Suspension [Lokelma]SBD90bf8e28-748d-4e4b-a19f-9cf483370eff28
2047639sodium zirconium cyclosilicate 5000 MG Powder for Oral Suspension [Lokelma]SBD90bf8e28-748d-4e4b-a19f-9cf483370eff28
2047642sodium zirconium cyclosilicate 10000 MG Powder for Oral SuspensionSCD90bf8e28-748d-4e4b-a19f-9cf483370eff28
2047633sodium zirconium cyclosilicate 5000 MG Powder for Oral SuspensionSCD90bf8e28-748d-4e4b-a19f-9cf483370eff28
2053927Lokelma 10 GM Powder for Oral SuspensionSY90bf8e28-748d-4e4b-a19f-9cf483370eff28
2053927Lokelma 10000 MG Powder for Oral SuspensionSY90bf8e28-748d-4e4b-a19f-9cf483370eff28
2047639Lokelma 5 GM Powder for Oral SuspensionSY90bf8e28-748d-4e4b-a19f-9cf483370eff28
2047639Lokelma 5000 MG Powder for Oral SuspensionSY90bf8e28-748d-4e4b-a19f-9cf483370eff28
2047642sodium zirconium cyclosilicate 10 GM Powder for Oral SuspensionSY90bf8e28-748d-4e4b-a19f-9cf483370eff28
2047633sodium zirconium cyclosilicate 5 GM Powder for Oral SuspensionSY90bf8e28-748d-4e4b-a19f-9cf483370eff28
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 startMarketing endSampleExclude flagStatus
0310-1110-010031011100110 g in 1 PACKET10 gHistorical
0310-1110-300031011103030 PACKET in 1 BOX (0310-1110-30) / 10 g in 1 PACKET (0310-1110-01) 30 packet2018-09-040000-00-00NoNoCurrent
0310-1110-390031011103911 PACKET in 1 BOX (0310-1110-39) / 10 g in 1 PACKET (0310-1110-01) 11 packet2019-01-020000-00-00NoNoCurrent
0310-1110-910031011109110 g in 1 PACKET10 gHistorical
0310-1110-93003101110933 PACKET in 1 BOX (0310-1110-93) / 10 g in 1 PACKET (0310-1110-91) 3 packet2024-02-01YesNoHistorical
0310-1110-940031011109411 PACKET in 1 BOX (0310-1110-94) > 10 g in 1 PACKET (0310-1110-91) 11 packet2019-02-010000-00-00NoNoCurrent
0310-1110-980031011109830 PACKET in 1 BOX (0310-1110-98) > 10 g in 1 PACKET (0310-1110-91) 30 packet2018-09-042021-07-31NoNoCurrent