budesonide inhalation

Product NDC
50090-7126
11-digit product format
500907126
Labeler code
50090
Product ID
50090-7126_f8778e56-3cf8-4dc1-bd31-0aab39627a42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
budesonide inhalation
Dosage form
SUSPENSION
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
ANDA210897
Marketing category
ANDA
Marketing start
2019-05-21
Substance
BUDESONIDE
Active strength
.5 mg/2mL
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
50090-7126-0500907126006 POUCH in 1 CARTON (50090-7126-0) / 10 mL in 1 POUCH6 pouch2024-04-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
budesonide inhalationA-S Medication Solutions2025-04-01HUMAN PRESCRIPTION DRUG LABEL4