FDA.reportPublic FDA data

Azithromycin

Product NDC
53002-2228
11-digit product format
530022228
Labeler code
53002
Product ID
53002-2228_ab7441f2-b075-420e-9d56-c4aa5e1be027
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA065225
Marketing category
ANDA
Marketing start
2006-01-06
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 mg/1
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
53002-2228-12023-01-30C16284748780-19d75b9cf-ec0c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
53002-2228-12021-01-07C16284748780-19d75b9cf-ec0c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
53002-2228-12020-01-31C16284748780-19d75b9cf-ec0c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2228-1Azithromycin6 in 1 DOSE PACKTABLET, FILM COATED63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2228AZITHROMYCIN TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 1 package rows20210107_f454c421-ebbe-4a58-b9fa-000dab90a6e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKf454c421-ebbe-4a58-b9fa-000dab90a6e03
308460azithromycin 250 MG Oral TabletPSNf454c421-ebbe-4a58-b9fa-000dab90a6e03
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNf454c421-ebbe-4a58-b9fa-000dab90a6e03
308460azithromycin 250 MG Oral TabletSCDf454c421-ebbe-4a58-b9fa-000dab90a6e03
749783azithromycin 250 MG Oral Tablet 6 Count PackSYf454c421-ebbe-4a58-b9fa-000dab90a6e03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-2228-1530022228016 TABLET, FILM COATED in 1 DOSE PACK (53002-2228-1) 2017-10-010000-00-00NoNoCurrent