AZITHROMYCIN DIHYDRATE

Product NDC
63126-402
11-digit product format
631260402
Labeler code
63126
Product ID
63126-402_171d7bd6-0435-4ffb-b126-e3f966433b0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN DIHYDRATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Yung Shin Pharmaceutical Ind. Co., Ltd.
Application
ANDA211318
Marketing category
ANDA
Marketing start
2021-08-31
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63126-402-306312604023030 TABLET, FILM COATED in 1 BOTTLE (63126-402-30) 2021-08-310000-00-00NoNoCurrent