Azithromycin

Product NDC
63629-8034
11-digit product format
636298034
Labeler code
63629
Product ID
63629-8034_bd5f5c77-4126-467a-9b92-1da322f1d34a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207398
Marketing category
ANDA
Marketing start
2018-07-05
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 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
63629-8034-12024-09-09C16284748780-11030e365-630d-111a-e063-dadaa90a10e2bd5f5c77-4126-467a-9b92-1da322f1d34a
63629-8034-12024-01-30C16284748780-11030e365-630d-111a-e063-dadaa90a10e2bd5f5c77-4126-467a-9b92-1da322f1d34a

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8034-1636298034015 TABLET, FILM COATED in 1 BOTTLE (63629-8034-1) 2019-07-180000-00-00NoNoCurrent