Budesonide

Product NDC
46122-389
11-digit product format
461220389
Labeler code
46122
Product ID
46122-389_6cbd5b0f-8a4c-f704-98fc-42f657057972
Type
HUMAN OTC DRUG
Nonproprietary name
Budesonide
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Amerisource Bergen
Application
ANDA078949
Marketing category
ANDA
Marketing start
2016-09-15
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-389-76ML - Milliliter46122-3896542cd36-e98b-43fd-b330-dbf7240428dd12017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-389BUDESONIDE SPRAY, METERED [AMERISOURCE BERGEN]7Legacy NDC20241004_ab2e6644-912c-7d39-8ee4-039152ee3db2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-389-76461220389761 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (46122-389-76) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY2016-09-150000-00-00NoNoCurrent