AZITHROMYCIN

Product NDC
68788-7636
11-digit product format
687887636
Labeler code
68788
Product ID
68788-7636_5c455afb-b5d6-466d-abf8-9ac9b158ceca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA207531
Marketing category
ANDA
Marketing start
2020-03-10
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
100 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7636-1ML - Milliliter68788-76361da4ea68-df85-4f36-b7d3-9a33a248570912020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7636AZITHROMYCIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.]6Legacy NDC20250207_3562f797-1458-43ac-b618-26e5414da9db.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7636-16878876360115 mL in 1 BOTTLE, PLASTIC (68788-7636-1) 15 ml2020-03-100000-00-00NoNoCurrent