Azithromycin

Product NDC
67296-0192
11-digit product format
672960192
Labeler code
67296
Product ID
67296-0192_9c9a737b-3d27-e142-e053-2995a90a49a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA065153
Marketing category
ANDA
Marketing start
2005-11-16
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
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
67296-0192-12022-01-28C16284748780-1d6a99b39-36d7-a426-e053-dadaa90af4c242780e26-52d7-5914-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0192-1Azithromycin6 in 1 BOTTLETABLET, FILM COATED62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0192AZITHROMYCIN TABLET, FILM COATED [REDPHARM DRUG, INC.]2Legacy NDC, 1 package rows20200121_42780e26-52d7-5914-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK42780e26-52d7-5914-e054-00144ff88e882
308460azithromycin 250 MG Oral TabletPSN42780e26-52d7-5914-e054-00144ff88e882
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN42780e26-52d7-5914-e054-00144ff88e882
308460azithromycin 250 MG Oral TabletSCD42780e26-52d7-5914-e054-00144ff88e882
749783azithromycin 250 MG Oral Tablet 6 Count PackSY42780e26-52d7-5914-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-0192-1672960192016 TABLET, FILM COATED in 1 BOTTLE (67296-0192-1) 2005-11-160000-00-00NoNoCurrent