azithromycin monohydrate

Product NDC

57297-161

11-digit product format

572970161

Labeler code

57297

Product ID

57297-161_b6353b0e-9818-46b3-81fd-d9dae8bf62c6

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

azithromycin monohydrate

Dosage form

TABLET

Route

ORAL

Labeler

LUPIN LIMITED

Application

ANDA065399

Marketing category

ANDA

Marketing start

2015-07-22

Marketing end

0000-00-00

Substance

AZITHROMYCIN MONOHYDRATE

Active strength

500 mg/1

Pharmacologic classes

Macrolide Antimicrobial [EPC],Macrolides [CS]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record