Azithromycin

Product NDC
0781-5793
11-digit product format
007815793
Labeler code
0781
Product ID
0781-5793_e46be1d8-714d-4158-8df0-94e3f56a3ffa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA065209
Marketing category
ANDA
Marketing start
2005-11-14
Marketing end
2022-12-31
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
600 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-5793-310078157933130 TABLET, FILM COATED in 1 BOTTLE (0781-5793-31) 2017-03-020000-00-00NoNoCurrent