Azithromycin

Product NDC

43063-540

11-digit product format

430630540

Labeler code

43063

Product ID

43063-540_aa6dd772-3233-b4c2-e053-2a95a90a75f9

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Azithromycin

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

PD-Rx Pharmaceuticals, Inc.

Application

ANDA065212

Marketing category

ANDA

Marketing start

2005-11-14

Marketing end

2020-09-30

Substance

AZITHROMYCIN MONOHYDRATE

Active strength

500 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