PULMICORT FLEXHALER

Product NDC
50090-6796
11-digit product format
500906796
Labeler code
50090
Product ID
50090-6796_ce8a32cf-d41e-4ffa-a5b0-61b6f78d49cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
AEROSOL, POWDER
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
NDA021949
Marketing category
NDA
Marketing start
2007-03-19
Substance
BUDESONIDE
Active strength
180 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
Q3OKS62Q6XBUDESONIDE51333-22-3BUDESONIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6796-0500906796001 INHALER in 1 CARTON (50090-6796-0) / 120 AEROSOL, POWDER in 1 INHALER1 inhaler2023-11-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PULMICORT FLEXHALER - A-S Medication SolutionsA-S Medication Solutions2023-11-07HUMAN PRESCRIPTION DRUG LABEL2