Budesonide Inhalation

Product NDC

68788-3768

11-digit product format

687883768

Labeler code

68788

Product ID

68788-3768_acb6a7d6-802f-41cb-865a-4f0b05690301

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Budesonide

Dosage form

SUSPENSION

Route

RESPIRATORY (INHALATION)

Labeler

Preferred Pharmaceuticals Inc.

Application

ANDA078404

Marketing category

ANDA

Marketing start

2015-08-17

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