NDC 68788-3768

Budesonide Inhalation

Budesonide

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

Product ID68788-3768_acb6a7d6-802f-41cb-865a-4f0b05690301
NDC68788-3768
Product TypeHuman Prescription Drug
Proprietary NameBudesonide Inhalation
Generic NameBudesonide
Dosage FormSuspension
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2015-08-17
Marketing CategoryANDA / ANDA
Application NumberANDA078404
Labeler NamePreferred Pharmaceuticals Inc.
Substance NameBUDESONIDE
Active Ingredient Strength1 mg/2mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68788-3768-3

30 mL in 1 VIAL (68788-3768-3)
Marketing Start Date2015-08-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-3768-3 [68788376803]

Budesonide Inhalation SUSPENSION
Marketing CategoryANDA
Application NumberANDA078404
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-08-17
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BUDESONIDE.5 mg/2mL

OpenFDA Data

SPL SET ID:cbec80f7-a85d-475d-bdbd-f940d7faadea
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351109

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0115-1687Budesonide InhalationBudesonide
    0115-1689Budesonide InhalationBudesonide
    68788-3768Budesonide InhalationBudesonide Inhalation
    68180-984budesonide inhalationbudesonide inhalation
    60687-524Budesonide InhalationBudesonide Inhalation
    0093-6815BudesonideBudesonide
    0093-6816BudesonideBudesonide
    0093-6817BudesonideBudesonide
    0093-7445BudesonideBudesonide
    0186-0916PULMICORTBudesonide
    0186-0917PULMICORTBudesonide
    0186-1988PULMICORT RESPULESBudesonide
    0186-1989PULMICORT RESPULESBudesonide
    0186-1990PULMICORT RESPULESBudesonide
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