FDA.reportPublic FDA data

Azithromycin

Product NDC
50090-5366
11-digit product format
500905366
Labeler code
50090
Product ID
50090-5366_8d368b7b-503b-4e04-b13c-ec56f189191f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207398
Marketing category
ANDA
Marketing start
2018-07-05
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui248656

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
50090-5366-02023-02-07C16284748780-1f386c649-d167-0266-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
50090-5366-12023-02-07C16284748780-1f386c649-d167-0266-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
50090-5366-02023-01-30C16284748780-1f386c649-d167-0266-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
50090-5366-12023-01-30C16284748780-1f386c649-d167-0266-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
50090-5366-0Azithromycin5 in 1 BOTTLETABLET, FILM COATED511
50090-5366-1Azithromycin1 in 1 BOTTLETABLET, FILM COATED111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5366AZITHROMYCIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20230919_77c5e4c6-6d16-40fe-bf36-cb441348f39b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN77c5e4c6-6d16-40fe-bf36-cb441348f39b11
248656azithromycin 500 MG Oral TabletSCD77c5e4c6-6d16-40fe-bf36-cb441348f39b11
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY77c5e4c6-6d16-40fe-bf36-cb441348f39b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5366-0500905366005 TABLET, FILM COATED in 1 BOTTLE (50090-5366-0) 2020-11-170000-00-00NoNoCurrent
50090-5366-1500905366011 TABLET, FILM COATED in 1 BOTTLE (50090-5366-1) 2020-11-170000-00-00NoNoCurrent