NDC 68788-7314

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 ID68788-7314_6b75cd89-4e3e-4f19-bd3d-1749d9f8eac8
NDC68788-7314
Product TypeHuman Prescription Drug
Proprietary NameBudesonide Inhalation Suspension
Generic NameBudesonide
Dosage FormInhalant
Route of AdministrationORAL
Marketing Start Date2019-01-02
Marketing CategoryANDA / ANDA
Application NumberANDA205710
Labeler NamePreferred Pharmaceuticals Inc.
Substance NameBUDESONIDE
Active Ingredient Strength1 mg/2mL
Pharm ClassesCorticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68788-7314-3

6 POUCH in 1 CARTON (68788-7314-3) > 5 AMPULE in 1 POUCH > 2 mL in 1 AMPULE
Marketing Start Date2019-01-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-7314-3 [68788731403]

Budesonide Inhalation Suspension INHALANT
Marketing CategoryANDA
Application NumberANDA205710
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-01-02

Drug Details

Active Ingredients

IngredientStrength
BUDESONIDE.5 mg/2mL

OpenFDA Data

SPL SET ID:dcb35488-23c5-4e7b-ab86-8406cf855748
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351109

    • 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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