Budesonide

Product NDC
60505-0820
11-digit product format
605050820
Labeler code
60505
Product ID
60505-0820_19e56efe-5076-e888-4634-1fcff544a418
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
SUSPENSION
Route
RESPIRATORY (INHALATION)
Labeler
Apotex Corp.
Application
ANDA078202
Marketing category
ANDA
Marketing start
2009-03-30
Marketing end
2021-06-20
Substance
BUDESONIDE
Active strength
0 mg/2mL
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0820-06050508200030 AMPULE in 1 CARTON (60505-0820-0) > 2 mL in 1 AMPULE30 ampule2009-03-302021-06-20NoNoCurrent