FDA.reportPublic FDA data

Azithromycin

Product NDC
53002-0470
11-digit product format
530020470
Labeler code
53002
Product ID
53002-0470_99097283-62b3-4d4f-bc3a-d3ffea471336
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA065223
Marketing category
ANDA
Marketing start
2006-01-06
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
53002-0470-12023-01-30C16284748780-19d75b9d0-6f43-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
53002-0470-12021-01-07C16284748780-19d75b9d0-6f43-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
53002-0470-12020-01-31C16284748780-19d75b9d0-6f43-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
53002-0470-1Azithromycin3 in 1 DOSE PACKTABLET, FILM COATED35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0470AZITHROMYCIN TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 1 package rows20210107_cd108535-4bc5-4d5b-a3c1-6fb9f533194d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
308460azithromycin 250 MG Oral TabletPSNcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
248656azithromycin 500 MG Oral TabletPSNcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
308460azithromycin 250 MG Oral TabletSCDcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
248656azithromycin 500 MG Oral TabletSCDcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
749780azithromycin 500 MG Oral Tablet 3 Count PackSYcd108535-4bc5-4d5b-a3c1-6fb9f533194d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-0470-1530020470013 TABLET, FILM COATED in 1 DOSE PACK (53002-0470-1) 2017-10-010000-00-00NoNoCurrent