FDA.reportPublic FDA data

Azithromycin

Product NDC
53217-263
11-digit product format
532170263
Labeler code
53217
Product ID
53217-263_e93d2a8a-9553-4318-a684-b30487bdf9f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA065225
Marketing category
ANDA
Marketing start
2006-01-06
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
53217-263-012020-01-31C16284748780-19d75b9d0-81a6-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
53217-263-01Azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED64
53217-263-01Azithromycin1 in 1 CARTONTABLET, FILM COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-263-01EA - Each53217-2638b73bd3a-f37f-42de-82cf-7303b832e7cc12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-263AZITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]4Legacy NDC, 2 package rows20170313_77f12139-2e38-4298-b4f4-c24976cf0636.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK77f12139-2e38-4298-b4f4-c24976cf06364
308460azithromycin 250 MG Oral TabletPSN77f12139-2e38-4298-b4f4-c24976cf06364
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN77f12139-2e38-4298-b4f4-c24976cf06364
248656azithromycin 500 MG Oral TabletPSN77f12139-2e38-4298-b4f4-c24976cf06364
308460azithromycin 250 MG Oral TabletSCD77f12139-2e38-4298-b4f4-c24976cf06364
248656azithromycin 500 MG Oral TabletSCD77f12139-2e38-4298-b4f4-c24976cf06364
749783azithromycin 250 MG Oral Tablet 6 Count PackSY77f12139-2e38-4298-b4f4-c24976cf06364
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY77f12139-2e38-4298-b4f4-c24976cf06364

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-263-01532170263016 in 1 BLISTER PACKHistorical