Azithromycin

Product NDC
68788-7320
11-digit product format
687887320
Labeler code
68788
Product ID
68788-7320_75633f1d-50bd-4c1f-bc9e-c6fc3f7972fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA211147
Marketing category
ANDA
Marketing start
2018-08-06
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
100 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7320-1ML - Milliliter68788-7320089465ae-2de5-40a6-9977-e0664900a66e12020-09-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7320-1687887320015 mL in 1 BOTTLE (68788-7320-1) 5 ml2019-10-160000-00-00NoNoCurrent