Azithromycin

Product NDC
60505-6076
11-digit product format
605056076
Labeler code
60505
Product ID
60505-6076_a64b0776-7c2f-c4e7-fe3a-e3f9b25650b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin for injection injection, powder, lyophilized, for solution
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
APOTEX CORP.
Application
ANDA065501
Marketing category
ANDA
Marketing start
2010-04-25
Marketing end
2022-03-31
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
500 mg/10mL
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
60505-6076-46050560760410 VIAL in 1 CARTON (60505-6076-4) > 10 mL in 1 VIAL10 vial2010-04-252022-03-31NoNoCurrent