Azithromycin Dihydrate

Product NDC
68788-8101
11-digit product format
687888101
Labeler code
68788
Product ID
68788-8101_1ad4ced9-291d-42e2-ac28-87ac2262bd02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA208250
Marketing category
ANDA
Marketing start
2021-10-08
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 mg/1
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
68788-8101-6EA - Each68788-8101b0f349d2-aa75-40d5-a124-cd4c0bbe3f0b12021-12-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8101-6687888101061 BLISTER PACK in 1 CARTON (68788-8101-6) > 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2021-10-080000-00-00NoNoCurrent