FDA.reportPublic FDA data

Azithromycin

Product NDC
50090-0983
11-digit product format
500900983
Labeler code
50090
Product ID
50090-0983_a132478d-10a1-4fd5-aeac-ec72c3d14d56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065246
Marketing category
ANDA
Marketing start
2010-12-17
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
200 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0983-02023-01-30C16284748780-19d75b9d0-9b4a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AZITHROMYCIN FOR ORAL SUSPENSION. AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
50090-0983-02021-09-11C16284748780-19d75b9d0-9b4a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AZITHROMYCIN FOR ORAL SUSPENSION. AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
50090-0983-02020-01-31C16284748780-19d75b9d0-9b4a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AZITHROMYCIN FOR ORAL SUSPENSION. AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0983-0Azithromycin22.5 mL in 1 BOTTLEPOWDER, FOR SUSPENSION22.511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0983-0ML - Milliliter50090-09837abf9767-ea67-43e7-967a-c838baa40f9612018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0983AZITHROMYCIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]11Legacy NDC, 1 package rows20210912_ecba20f2-da3e-41be-a4e1-d9016634f831.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141963azithromycin 200 MG in 5 mL Oral SuspensionPSNecba20f2-da3e-41be-a4e1-d9016634f83111
141963azithromycin 40 MG/ML Oral SuspensionSCDecba20f2-da3e-41be-a4e1-d9016634f83111
141963azithromycin 1200 MG per 30 ML Oral SuspensionSYecba20f2-da3e-41be-a4e1-d9016634f83111
141963azithromycin 200 MG per 5 ML Oral SuspensionSYecba20f2-da3e-41be-a4e1-d9016634f83111
141963azithromycin 600 MG per 15 ML Oral SuspensionSYecba20f2-da3e-41be-a4e1-d9016634f83111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0983-05009009830022.5 mL in 1 BOTTLE (50090-0983-0) 22.5 ml2014-11-280000-00-00NoNoCurrent