FDA.reportPublic FDA data

azithromycin

Product NDC
50090-2509
11-digit product format
500902509
Labeler code
50090
Product ID
50090-2509_35d071e2-33a3-49a2-85da-9839f1dc123f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA050710
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1995-10-19
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
1200 mg/30mL
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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
50090-2509-02024-01-30C16284748780-11030e365-4795-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 250 mg and 500 mg tablets, for oral use AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2509-0azithromycin1 in 1 CARTONPOWDER, FOR SUSPENSION112
50090-2509-0azithromycin30 mL in 1 BOTTLEPOWDER, FOR SUSPENSION3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2509-0ML - Milliliter50090-250975fc7b56-da80-431f-83b2-541bca9d787112019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2509AZITHROMYCIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]12Legacy NDC, 2 package rows20220518_e297fd4b-e0f7-4257-9827-729f936e2ba9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141963azithromycin 200 MG in 5 mL Oral SuspensionPSNe297fd4b-e0f7-4257-9827-729f936e2ba912
141963azithromycin 40 MG/ML Oral SuspensionSCDe297fd4b-e0f7-4257-9827-729f936e2ba912
141963azithromycin 1200 MG per 30 ML Oral SuspensionSYe297fd4b-e0f7-4257-9827-729f936e2ba912
141963azithromycin 200 MG per 5 ML Oral SuspensionSYe297fd4b-e0f7-4257-9827-729f936e2ba912
141963azithromycin 600 MG per 15 ML Oral SuspensionSYe297fd4b-e0f7-4257-9827-729f936e2ba912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2509-0500902509001 BOTTLE in 1 CARTON (50090-2509-0) > 30 mL in 1 BOTTLE1 bottle2016-10-140000-00-00NoNoCurrent