Budesonide

Product NDC
60505-6194
11-digit product format
605056194
Labeler code
60505
Product ID
60505-6194_08cf739d-267d-26ce-3128-6f460c8470c7
Type
HUMAN OTC DRUG
Nonproprietary name
Budesonide
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Apotex Corp.
Application
ANDA078949
Marketing category
ANDA
Marketing start
2018-04-26
Marketing end
0000-00-00
Substance
BUDESONIDE
Active strength
32 ug/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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-6194-3605056194031 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (60505-6194-3) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY2018-04-260000-00-00NoNoCurrent