azithromycin monohydrate

Product NDC
55154-8094
11-digit product format
551548094
Labeler code
55154
Product ID
55154-8094_6826ad94-7137-4b02-9ab4-826134322284
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin monohydrate
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA065398
Marketing category
ANDA
Marketing start
2015-08-18
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-8094-05515480940010 BLISTER PACK in 1 BAG (55154-8094-0) > 1 TABLET in 1 BLISTER PACK10 blister pack2015-08-180000-00-00NoNoCurrent