azithromycin monohydrate

Product NDC

57297-162

11-digit product format

572970162

Labeler code

57297

Product ID

57297-162_0d4e2766-a243-44a9-801e-b4e4abcc59a2

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

azithromycin monohydrate

Dosage form

TABLET

Route

ORAL

Labeler

LUPIN LIMITED

Application

ANDA065400

Marketing category

ANDA

Marketing start

2015-07-22

Marketing end

0000-00-00

Substance

AZITHROMYCIN MONOHYDRATE

Active strength

600 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