FDA.reportPublic FDA data

Azithromycin

Product NDC
71335-1755
11-digit product format
713351755
Labeler code
71335
Product ID
71335-1755_02fdd8ac-5daf-42bc-933e-e33c2e4cf3f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210001
Marketing category
ANDA
Marketing start
2019-03-12
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
71335-1755-12024-05-17C16284748780-11030e365-3cde-111a-e063-dadaa90a10e2These 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
71335-1755-22024-05-17C16284748780-11030e365-3cde-111a-e063-dadaa90a10e2These 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
71335-1755-12024-01-30C16284748780-11030e365-3cde-111a-e063-dadaa90a10e2These 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
71335-1755-22024-01-30C16284748780-11030e365-3cde-111a-e063-dadaa90a10e2These 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
71335-1755-1Azithromycin30 in 1 BOTTLETABLET, FILM COATED30103
71335-1755-2Azithromycin5 in 1 BOTTLETABLET, FILM COATED5103
71335-1755-3Azithromycin2 in 1 BOTTLETABLET, FILM COATED2103
71335-1755-4Azithromycin6 in 1 BOTTLETABLET, FILM COATED6103
71335-1755-5Azithromycin4 in 1 BOTTLETABLET, FILM COATED4103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1755AZITHROMYCIN TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20250226_b5d79719-b1dc-469f-a19c-f8ba615138f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSNb5d79719-b1dc-469f-a19c-f8ba615138f0103
248656azithromycin 500 MG Oral TabletSCDb5d79719-b1dc-469f-a19c-f8ba615138f0103
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYb5d79719-b1dc-469f-a19c-f8ba615138f0103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1755-17133517550130 TABLET, FILM COATED in 1 BOTTLE (71335-1755-1) 2025-01-300000-00-00NoNoCurrent
71335-1755-2713351755025 TABLET, FILM COATED in 1 BOTTLE (71335-1755-2) 2020-12-300000-00-00NoNoCurrent
71335-1755-3713351755032 TABLET, FILM COATED in 1 BOTTLE (71335-1755-3) 2025-01-30NoNoHistorical
71335-1755-4713351755046 TABLET, FILM COATED in 1 BOTTLE (71335-1755-4) 2025-01-30NoNoHistorical
71335-1755-5713351755054 TABLET, FILM COATED in 1 BOTTLE (71335-1755-5) 2025-01-30NoNoHistorical