BUDESONIDE (ENTERIC COATED)

Product NDC

55700-590

11-digit product format

557000590

Labeler code

55700

Product ID

55700-590_d7542bae-81ef-4e96-ad2b-203b7c94b060

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Budesonide

Dosage form

CAPSULE, DELAYED RELEASE PELLETS

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA206623

Marketing category

ANDA

Marketing start

2018-03-09

Marketing end

0000-00-00

Substance

BUDESONIDE

Active strength

3 mg/1

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