Azithromycin Dihydrate

Product NDC

50268-104

11-digit product format

502680104

Labeler code

50268

Product ID

50268-104_7e17404b-77dd-1a76-e053-2991aa0a82c9

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

azithromycin

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

AvPAK

Application

ANDA065509

Marketing category

ANDA

Marketing start

2016-11-16

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

2019-12-31

Current FDA listing

Historical FDA.report record