Azithromycin

Product NDC
68788-7307
11-digit product format
687887307
Labeler code
68788
Product ID
68788-7307_6dcde61a-d0cc-4be9-bb91-82373a1ead94
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
2020-02-12
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
200 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7307-3ML - Milliliter68788-7307cdb42197-ac04-41c8-8691-74701ab245d712020-04-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7307-3687887307031 BOTTLE in 1 CARTON (68788-7307-3) > 30 mL in 1 BOTTLE1 bottle2020-02-120000-00-00NoNoCurrent