FDA.reportPublic FDA data

Azithromycin

Product NDC
63629-7784
11-digit product format
636297784
Labeler code
63629
Product ID
63629-7784_962bd404-62b5-4a7f-8ad4-45284228ac0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA065405
Marketing category
ANDA
Marketing start
2008-02-11
Marketing end
0000-00-00
Substance
AZITHROMYCIN ANHYDROUS
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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
63629-7784-12024-01-30C16284748780-19d75b9d0-6469-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
63629-7784-12021-01-07C16284748780-19d75b9d0-6469-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
63629-7784-12020-01-31C16284748780-19d75b9d0-6469-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
63629-7784-1Azithromycin2 in 1 BOTTLETABLET, FILM COATED25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7784AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [BRYANT RANCH PREPACK]5Legacy NDC, 1 package rows20220225_962bd404-62b5-4a7f-8ad4-45284228ac0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN962bd404-62b5-4a7f-8ad4-45284228ac0f5
248656azithromycin 500 MG Oral TabletSCD962bd404-62b5-4a7f-8ad4-45284228ac0f5
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY962bd404-62b5-4a7f-8ad4-45284228ac0f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7784-1636297784012 TABLET, FILM COATED in 1 BOTTLE (63629-7784-1) 2008-02-110000-00-00NoNoCurrent