FDA.reportPublic FDA data

Azithromycin

Product NDC
53217-173
11-digit product format
532170173
Labeler code
53217
Product ID
53217-173_fc239fb9-8398-44a7-9eaa-73d6f2a453e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals 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
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
53217-173-012020-01-31C16284748780-19d75b9d0-5308-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS, USP. Azithromycin Tablets, USP 250 mg and 500 mg Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-173-01Azithromycin6 in 1 DOSE PACKTABLET, FILM COATED61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-173AZITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20151211_4ece67c7-b351-48bf-8488-823827952272.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK4ece67c7-b351-48bf-8488-8238279522721
308460azithromycin 250 MG Oral TabletPSN4ece67c7-b351-48bf-8488-8238279522721
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN4ece67c7-b351-48bf-8488-8238279522721
308460azithromycin 250 MG Oral TabletSCD4ece67c7-b351-48bf-8488-8238279522721
749783azithromycin 250 MG Oral Tablet 6 Count PackSY4ece67c7-b351-48bf-8488-8238279522721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-173-01532170173016 in 1 DOSE PACKHistorical