NDC 60687-524

Budesonide Inhalation

Budesonide Inhalation

Budesonide Inhalation is a Respiratory (inhalation) Suspension in the Human Prescription Drug category. It is labeled and distributed by American Health Packaging. The primary component is Budesonide.

Product ID60687-524_9973e448-74d5-12c2-e053-2995a90a2e79
NDC60687-524
Product TypeHuman Prescription Drug
Proprietary NameBudesonide Inhalation
Generic NameBudesonide Inhalation
Dosage FormSuspension
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2019-12-15
Marketing CategoryANDA / ANDA
Application NumberANDA210897
Labeler NameAmerican Health Packaging
Substance NameBUDESONIDE
Active Ingredient Strength1 mg/2mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 60687-524-83

30 POUCH in 1 CARTON (60687-524-83) > 1 AMPULE in 1 POUCH (60687-524-79) > 2 mL in 1 AMPULE
Marketing Start Date2019-12-15
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
BUDESONIDE.5 mg/2mL

Pharmacological Class

  • Corticosteroid [EPC]
  • Corticosteroid Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "Budesonide Inhalation" or generic name "Budesonide Inhalation"

NDCBrand NameGeneric Name
0115-1687Budesonide InhalationBudesonide
0115-1689Budesonide InhalationBudesonide
68788-3768Budesonide InhalationBudesonide
68180-984budesonide inhalationbudesonide inhalation
60687-524Budesonide InhalationBudesonide Inhalation
65302-042Budesonide InhalationBudesonide Inhalation Suspension

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.