Budesonide Inhalation

Product NDC

65302-042

11-digit product format

653020042

Labeler code

65302

Product ID

65302-042_9a27fc4e-5c1e-9e9b-e053-2995a90aaa20

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Budesonide Inhalation Suspension

Dosage form

SUSPENSION

Route

RESPIRATORY (INHALATION)

Labeler

The Ritedose Corporation

Application

ANDA210897

Marketing category

ANDA

Marketing start

2019-05-21

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

2020-12-31

Current FDA listing

Historical FDA.report record