Azithromycin Dihydrate

Product NDC

68788-9521

11-digit product format

687889521

Labeler code

68788

Product ID

68788-9521_2631f28c-4714-43f0-b4c9-e1afdf194458

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

azithromycin

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Preferred Pharmaceuticals, Inc.

Application

ANDA065509

Marketing category

ANDA

Marketing start

2014-02-06

Marketing end

0000-00-00

Substance

AZITHROMYCIN DIHYDRATE

Active strength

500 mg/1

Pharmacologic classes

Macrolide Antimicrobial [EPC],Macrolides [CS]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record