Azithromycin

Product NDC
71335-1195
11-digit product format
713351195
Labeler code
71335
Product ID
71335-1195_4c3e46ac-d890-41aa-8b6e-907010d62530
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1195-12024-09-12C16284748780-11030e365-0bd2-111a-e063-dadaa90a10e24c3e46ac-d890-41aa-8b6e-907010d62530
71335-1195-12024-01-30C16284748780-11030e365-0bd2-111a-e063-dadaa90a10e24c3e46ac-d890-41aa-8b6e-907010d62530

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1195-1713351195016 TABLET, FILM COATED in 1 BOTTLE (71335-1195-1) 2019-04-190000-00-00NoNoCurrent