NDC 76282-642

Budesonide Inhalation Suspension

Budesonide

Budesonide Inhalation Suspension is a Oral Inhalant in the Human Prescription Drug category. It is labeled and distributed by Exelan Pharmaceuticals, Inc.. The primary component is Budesonide.

Product ID76282-642_93738738-1b42-4f8e-bff3-8395eff662c5
NDC76282-642
Product TypeHuman Prescription Drug
Proprietary NameBudesonide Inhalation Suspension
Generic NameBudesonide
Dosage FormInhalant
Route of AdministrationORAL
Marketing Start Date2019-04-19
Marketing CategoryANDA / ANDA
Application NumberANDA205710
Labeler NameExelan Pharmaceuticals, Inc.
Substance NameBUDESONIDE
Active Ingredient Strength1 mg/2mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 76282-642-38

6 POUCH in 1 CARTON (76282-642-38) > 5 AMPULE in 1 POUCH (76282-642-37) > 2 mL in 1 AMPULE
Marketing Start Date2019-04-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76282-642-37 [76282064237]

Budesonide Inhalation Suspension INHALANT
Marketing CategoryANDA
Application NumberANDA205710
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-04-19

NDC 76282-642-38 [76282064238]

Budesonide Inhalation Suspension INHALANT
Marketing CategoryANDA
Application NumberANDA205710
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-04-19

Drug Details

Active Ingredients

IngredientStrength
BUDESONIDE1 mg/2mL

OpenFDA Data

SPL SET ID:d9656442-4587-4867-9a8c-5f5b0402936e
Manufacturer
UNII
UPC Code
  • 0376282641379
  • 0376282642376

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    68788-7290Budesonide Inhalation SuspensionBudesonide Inhalation Suspension
    68788-7314Budesonide Inhalation SuspensionBudesonide Inhalation Suspension
    69097-318Budesonide Inhalation SuspensionBudesonide Inhalation Suspension
    69097-321Budesonide Inhalation SuspensionBudesonide Inhalation Suspension
    69097-319Budesonide Inhalation SuspensionBudesonide Inhalation Suspension
    76282-641Budesonide Inhalation SuspensionBudesonide Inhalation Suspension
    76282-642Budesonide Inhalation SuspensionBudesonide Inhalation Suspension
    76282-640Budesonide Inhalation SuspensionBudesonide Inhalation Suspension
    16714-018Budesonide Inhalation SuspensionBudesonide Inhalation Suspension
    16714-019Budesonide Inhalation SuspensionBudesonide Inhalation Suspension
    16714-020Budesonide Inhalation SuspensionBudesonide Inhalation Suspension
    0093-6815BudesonideBudesonide
    0093-6816BudesonideBudesonide
    0093-6817BudesonideBudesonide
    0093-7445BudesonideBudesonide
    0115-1687Budesonide InhalationBudesonide
    0115-1689Budesonide InhalationBudesonide
    0186-0916PULMICORTBudesonide
    0186-0917PULMICORTBudesonide
    0186-1988PULMICORT RESPULESBudesonide
    0186-1989PULMICORT RESPULESBudesonide
    0186-1990PULMICORT RESPULESBudesonide
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