Azithromycin

Product NDC

0781-1497

11-digit product format

007811497

Labeler code

0781

Product ID

0781-1497_b6a1cbe0-4765-40fd-b549-2c4dd288abfe

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Azithromycin

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Sandoz Inc

Application

ANDA065209

Marketing category

ANDA

Marketing start

2005-11-14

Marketing end

2020-09-30

Substance

AZITHROMYCIN MONOHYDRATE

Active strength

600 mg/1

Pharmacologic classes

Macrolide Antimicrobial [EPC],Macrolides [CS]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record