Azithromycin

Product NDC
67457-860
11-digit product format
674570860
Labeler code
67457
Product ID
67457-860_6b968365-5525-43db-ba1b-4fa70e62a041
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA065506
Marketing category
ANDA
Marketing start
2019-06-27
Marketing end
2021-11-30
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
500 mg/5mL
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-860-506745708605010 VIAL in 1 CARTON (67457-860-50) > 5 mL in 1 VIAL (67457-860-00) 10 vial2019-06-272021-11-30NoNoCurrent