azithromycin monohydrate

Product NDC

55700-432

11-digit product format

557000432

Labeler code

55700

Product ID

55700-432_bd15e457-4be3-4bc9-b14a-bdaffb8365ec

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

azithromycin monohydrate

Dosage form

TABLET

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA065398

Marketing category

ANDA

Marketing start

2015-07-22

Marketing end

0000-00-00

Substance

AZITHROMYCIN MONOHYDRATE

Active strength

250 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