Azithromycin

Product NDC
68788-7082
11-digit product format
687887082
Labeler code
68788
Product ID
68788-7082_ec449fb1-df69-4585-a3c2-e3ee44e82b43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065212
Marketing category
ANDA
Marketing start
2018-01-12
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7082-3687887082031 DOSE PACK in 1 CARTON (68788-7082-3) > 3 TABLET, FILM COATED in 1 DOSE PACK1 dose pack2018-01-120000-00-00NoNoCurrent
68788-7082-5687887082055 TABLET, FILM COATED in 1 BOTTLE (68788-7082-5) 2018-01-120000-00-00NoNoCurrent