NDC 68788-7290

Budesonide Inhalation Suspension

Budesonide

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

Product ID68788-7290_5ebb3748-ff07-45f9-941d-57a981f5cf95
NDC68788-7290
Product TypeHuman Prescription Drug
Proprietary NameBudesonide Inhalation Suspension
Generic NameBudesonide
Dosage FormInhalant
Route of AdministrationORAL
Marketing Start Date2019-01-21
Marketing CategoryANDA / ANDA
Application NumberANDA205710
Labeler NamePreferred Pharmaceuticals Inc.
Substance NameBUDESONIDE
Active Ingredient Strength0 mg/2mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68788-7290-3

6 POUCH in 1 CARTON (68788-7290-3) > 5 AMPULE in 1 POUCH > 2 mL in 1 AMPULE
Marketing Start Date2019-01-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-7290-3 [68788729003]

Budesonide Inhalation Suspension INHALANT
Marketing CategoryANDA
Application NumberANDA205710
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-01-21

Drug Details

Active Ingredients

IngredientStrength
BUDESONIDE.25 mg/2mL

OpenFDA Data

SPL SET ID:61b907a0-80f4-4a46-8d5b-29c2eedaa17a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349094

    • Pharmacological Class

    • 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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