Budesonide

Product NDC

0093-7445

11-digit product format

000937445

Labeler code

0093

Product ID

0093-7445_9906375b-66ff-430a-a719-76811d137714

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Budesonide

Dosage form

CAPSULE, DELAYED RELEASE PELLETS

Route

ORAL

Labeler

Teva Pharmaceuticals USA, Inc.

Application

ANDA090379

Marketing category

ANDA

Marketing start

2016-06-23

Marketing end

2021-01-31

Substance

BUDESONIDE

Active strength

3 mg/1

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record