FDA.reportPublic FDA data

azithromycin

Product NDC
71610-381
11-digit product format
716100381
Labeler code
71610
Product ID
71610-381_2b930ea4-fa18-4ef0-be78-7f8f715acc15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA050711
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-05-13
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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
71610-381-062023-01-30C16284748780-1f386c649-c881-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 250 mg and 500 mg tablets, for oral use AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-381-06azithromycin6 in 1 BOTTLETABLET, FILM COATED61

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-381-06EA - Each71610-381f63dfb66-5f7c-4b02-add2-2733fdbca9c812020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-381AZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 1 package rows20200125_2414dc57-e373-485a-bc8e-b86c2aeb1d38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK2414dc57-e373-485a-bc8e-b86c2aeb1d381
308460azithromycin 250 MG Oral TabletPSN2414dc57-e373-485a-bc8e-b86c2aeb1d381
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN2414dc57-e373-485a-bc8e-b86c2aeb1d381
308460azithromycin 250 MG Oral TabletSCD2414dc57-e373-485a-bc8e-b86c2aeb1d381
749783azithromycin 250 MG Oral Tablet 6 Count PackSY2414dc57-e373-485a-bc8e-b86c2aeb1d381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-381-06716100381066 TABLET, FILM COATED in 1 BOTTLE (71610-381-06) 2020-01-020000-00-00NoNoCurrent