Ortikos

Product NDC
55566-1002
11-digit product format
555661002
Labeler code
55566
Product ID
55566-1002_69c1e200-f5ae-429f-b890-b2418700a7e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
CAPSULE
Route
ORAL
Labeler
Ferring Pharmaceuticals Inc.
Application
NDA211929
Marketing category
NDA
Marketing start
2020-07-20
Marketing end
0000-00-00
Substance
BUDESONIDE
Active strength
6 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55566-1002-15556610020130 CAPSULE in 1 BOTTLE (55566-1002-1) 30 capsule2020-07-200000-00-00NoNoCurrent