Azithromycin

Product NDC
43353-693
11-digit product format
433530693
Labeler code
43353
Product ID
43353-693_ddc19c82-dad2-4b79-abda-4730858afea8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA065211
Marketing category
ANDA
Marketing start
2005-11-14
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
43353-693-062020-01-31C16284748780-19d75b9d1-2b26-f424-e053-dadaa90a57ceAzithromycin Tablets, USP
43353-693-872020-01-31C16284748780-19d75b9d1-2b26-f424-e053-dadaa90a57ceAzithromycin Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-693-06Azithromycin6 in 1 BOTTLE, PLASTICTABLET, FILM COATED61
43353-693-87Azithromycin2400 in 1 BOTTLE, PLASTICTABLET, FILM COATED24001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-693AZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20140521_10aebebe-98b3-4f35-b9cb-dba5e3505f1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK10aebebe-98b3-4f35-b9cb-dba5e3505f1e1
308460azithromycin 250 MG Oral TabletPSN10aebebe-98b3-4f35-b9cb-dba5e3505f1e1
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN10aebebe-98b3-4f35-b9cb-dba5e3505f1e1
308460azithromycin 250 MG Oral TabletSCD10aebebe-98b3-4f35-b9cb-dba5e3505f1e1
749783azithromycin 250 MG Oral Tablet 6 Count PackSY10aebebe-98b3-4f35-b9cb-dba5e3505f1e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-693-06433530693066 in 1 BOTTLE, PLASTICHistorical
43353-693-87433530693872400 in 1 BOTTLE, PLASTICHistorical