FDA.reportPublic FDA data

NDC 0310-1105-01 - LOKELMA

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0310-1105
Requested NDC
0310-1105-01
Package NDCs from labels
0310-1105-01, 0310-1105-30, 0310-1105-39
Manufacturer
AstraZeneca Pharmaceuticals LP | AstraZeneca PLC
Effective date
2024-02-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LOKELMA - AstraZeneca Pharmaceuticals LP | AstraZeneca PLCAstraZeneca Pharmaceuticals LP | AstraZeneca PLC2024-02-08HUMAN PRESCRIPTION DRUG LABEL
LOKELMA - A-S Medication SolutionsA-S Medication Solutions2023-05-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-1105-01LOKELMA5 g in 1 PACKETPOWDER, FOR SUSPENSION528
0310-1105-30LOKELMA30 in 1 BOXPOWDER, FOR SUSPENSION3028
0310-1105-39LOKELMA11 in 1 BOXPOWDER, FOR SUSPENSION1128

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-1105LOKELMA (SODIUM ZIRCONIUM CYCLOSILICATE) POWDER, FOR SUSPENSION [ASTRAZENECA PHARMACEUTICALS LP]28Current NDC, Legacy NDC, 3 package rows20250213_90bf8e28-748d-4e4b-a19f-9cf483370eff.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-1105-01EA - Each0310-11059e6eb1af-a1fd-46ad-ac0f-b52cc82ae33312018-09-05
0310-1105-30EA - Each0310-11056df1fa31-e587-4b52-9a03-6a4b06206f5712018-09-05
0310-1105-39EA - Each0310-11059230ac25-2445-4335-b226-a2b008b273f312018-12-13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOKELMASODIUM ZIRCONIUM CYCLOSILICATEA-S Medication Solutions8833d6e6-33ab-4ea9-b78f-3ec30a904ef82026-03-26Warnings, Adverse reactionsExact identifier
application number: NDA207078
rxcui: 2053927
rxcui: 2047642
unii: D652ZWF066
LOKELMASODIUM ZIRCONIUM CYCLOSILICATEAstraZeneca Pharmaceuticals LP90bf8e28-748d-4e4b-a19f-9cf483370eff2024-02-08Warnings, Adverse reactionsExact identifier
application number: NDA207078
ndc (package): 0310-1110-93
ndc (package): 0310-1110-98
ndc (package): 0310-1110-91
ndc (package): 0310-1105-39
ndc (package): 0310-1110-01
ndc (package): 0310-1110-39
ndc (package): 0310-1110-30
ndc (package): 0310-1105-30
ndc (package): 0310-1110-94
ndc (package): 0310-1105-01
ndc (product): 0310-1110
ndc (product): 0310-1105
ndc11 (package): 00310110501
rxcui: 2053927
rxcui: 2047639
rxcui: 2047642
rxcui: 2047633
spl id: e97b97a9-6ad1-4b47-a5be-fefd7be47c23
spl set id: 90bf8e28-748d-4e4b-a19f-9cf483370eff
unii: D652ZWF066
LOKELMASODIUM ZIRCONIUM CYCLOSILICATEA-S Medication Solutions7f7ed64d-8480-4143-a207-29c24a0b93632023-05-31Warnings, Adverse reactionsExact identifier
application number: NDA207078
ndc (package): 50090-6502-0
ndc (product): 50090-6502
rxcui: 2047639
rxcui: 2047633
spl id: f69e7a3d-5f83-4022-939a-7e373d0b0cdb
spl set id: 7f7ed64d-8480-4143-a207-29c24a0b9363
unii: D652ZWF066

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.