Azithromycin

Product NDC

68788-9045

11-digit product format

687889045

Labeler code

68788

Product ID

68788-9045_10a31bb9-d93b-44ee-98d2-f4d24aab5680

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Azithromycin Monohydrate

Dosage form

POWDER, FOR SUSPENSION

Route

ORAL

Labeler

Preferred Pharmaceuticals, Inc.

Application

ANDA065419

Marketing category

ANDA

Marketing start

2011-03-10

Marketing end

0000-00-00

Substance

AZITHROMYCIN MONOHYDRATE

Active strength

100 mg/5mL

Pharmacologic classes

Macrolide Antimicrobial [EPC],Macrolides [CS]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record