AZITHROMYCIN

Product NDC
61919-383
11-digit product format
619190383
Labeler code
61919
Product ID
61919-383_357e043c-84aa-4247-b4f1-aff354266fbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DirectRX
Application
ANDA065223
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
61919-383-032020-01-31C16284748780-19d75b9d0-26c2-f424-e053-dadaa90a57ceAZITHROMYCIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-383-03AZITHROMYCIN3 in 1 BOTTLETABLET, FILM COATED31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-383AZITHROMYCIN TABLET, FILM COATED [DIRECTRX]1Legacy NDC, 1 package rows20151111_8c2d65e1-7fa4-49ee-aa12-0322fc303c28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN8c2d65e1-7fa4-49ee-aa12-0322fc303c281
248656azithromycin 500 MG Oral TabletSCD8c2d65e1-7fa4-49ee-aa12-0322fc303c281
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY8c2d65e1-7fa4-49ee-aa12-0322fc303c281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-383-03619190383033 in 1 BOTTLEHistorical