Budesonide

Product NDC

68788-0013

11-digit product format

687880013

Labeler code

68788

Product ID

68788-0013_d7bb85a7-aace-4d1b-9f24-8f86a809ccd8

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Budesonide

Dosage form

SUSPENSION

Route

RESPIRATORY (INHALATION)

Labeler

Preferred Pharmaceuticals, Inc.

Application

ANDA077519

Marketing category

ANDA

Marketing start

2009-02-04

Marketing end

0000-00-00

Substance

BUDESONIDE

Active strength

1 mg/2mL

Pharmacologic classes

Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record