azithromycin monohydrate

Product NDC
55700-832
11-digit product format
557000832
Labeler code
55700
Product ID
55700-832_ede284dc-4a6b-4316-b415-e1f5494f2797
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin monohydrate
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA065399
Marketing category
ANDA
Marketing start
2019-12-30
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-832-03557000832033 TABLET in 1 BLISTER PACK (55700-832-03) 3 tablet2019-12-300000-00-00NoNoCurrent