FDA.reportPublic FDA data

Azithromycin

Product NDC
53002-5221
11-digit product format
530025221
Labeler code
53002
Product ID
53002-5221_0979b2d8-0c37-48e4-b559-0a26b13bc109
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA065405
Marketing category
ANDA
Marketing start
2008-02-11
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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
53002-5221-22023-01-30C16284748780-1f386c649-cd18-0266-e053-dadaa90a7c1aThese 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
53002-5221-52023-01-30C16284748780-1f386c649-cd18-0266-e053-dadaa90a7c1aThese 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
53002-5221-62023-01-30C16284748780-1f386c649-cd18-0266-e053-dadaa90a7c1aThese 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
53002-5221-2Azithromycin2 in 1 BOTTLETABLET, FILM COATED21
53002-5221-5Azithromycin5 in 1 BOTTLETABLET, FILM COATED51
53002-5221-6Azithromycin6 in 1 BOTTLETABLET, FILM COATED61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-5221AZITHROMYCIN TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 3 package rows20210106_bbe9aca5-77b3-411f-863d-571de9a9a4b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSNbbe9aca5-77b3-411f-863d-571de9a9a4b61
248656azithromycin 500 MG Oral TabletSCDbbe9aca5-77b3-411f-863d-571de9a9a4b61
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYbbe9aca5-77b3-411f-863d-571de9a9a4b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-5221-2530025221022 TABLET, FILM COATED in 1 BOTTLE (53002-5221-2) 2019-01-010000-00-00NoNoCurrent
53002-5221-5530025221055 TABLET, FILM COATED in 1 BOTTLE (53002-5221-5) 2019-01-010000-00-00NoNoCurrent
53002-5221-6530025221066 TABLET, FILM COATED in 1 BOTTLE (53002-5221-6) 2019-01-010000-00-00NoNoCurrent