Budesonide Nasal

Product NDC
60505-0839
11-digit product format
605050839
Labeler code
60505
Product ID
60505-0839_84a02c06-6fbf-eb8a-4bfb-fc783a6b331a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Apotex Corp.
Application
ANDA078949
Marketing category
ANDA
Marketing start
2014-05-12
Marketing end
0000-00-00
Substance
BUDESONIDE
Active strength
32 ug/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0839-2GM - Gram60505-083988e2ef01-6b28-45d3-b008-e3984daa478612014-06-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0839-2605050839021 BOTTLE, SPRAY in 1 CARTON (60505-0839-2) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY2014-05-120000-00-00NoNoCurrent