FDA.reportPublic FDA data

Azithromycin

Product NDC
68071-2672
11-digit product format
680712672
Labeler code
68071
Product ID
68071-2672_dc8e486e-619e-4ee1-e053-2a95a90a7940
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA207370
Marketing category
ANDA
Marketing start
2018-07-05
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
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
68071-2672-22025-01-30C16284748780-12cef2736-68ad-d83d-e063-dadaa90ab31fThese 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
68071-2672-42025-01-30C16284748780-12cef2736-68ad-d83d-e063-dadaa90ab31fThese 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
68071-2672-2Azithromycin2 in 1 BOTTLETABLET, FILM COATED21
68071-2672-4Azithromycin4 in 1 BOTTLETABLET, FILM COATED41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2672AZITHROMYCIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20220414_dc8e486e-619f-4ee1-e053-2a95a90a7940.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSNdc8e486e-619f-4ee1-e053-2a95a90a79401
308460azithromycin 250 MG Oral TabletSCDdc8e486e-619f-4ee1-e053-2a95a90a79401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2672-2680712672022 TABLET, FILM COATED in 1 BOTTLE (68071-2672-2) 2022-04-130000-00-00NoNoCurrent
68071-2672-4680712672044 TABLET, FILM COATED in 1 BOTTLE (68071-2672-4) 2022-04-130000-00-00NoNoCurrent