NDC 0115-1689

Budesonide Inhalation

Budesonide

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

Product ID0115-1689_5edb1920-0ead-45ed-b52e-6856f5430591
NDC0115-1689
Product TypeHuman Prescription Drug
Proprietary NameBudesonide Inhalation
Generic NameBudesonide
Dosage FormSuspension
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2016-08-04
Marketing CategoryANDA / ANDA
Application NumberANDA078404
Labeler NameImpax Generics
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 0115-1689-74

6 POUCH in 1 CARTON (0115-1689-74) > 5 VIAL in 1 POUCH (0115-1689-76) > 2 mL in 1 VIAL
Marketing Start Date2016-08-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-1689-74 [00115168974]

Budesonide Inhalation SUSPENSION
Marketing CategoryANDA
Application NumberANDA078404
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-08-04

NDC 0115-1689-76 [00115168976]

Budesonide Inhalation SUSPENSION
Marketing CategoryANDA
Application NumberANDA078404
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-08-04

Drug Details

Active Ingredients

IngredientStrength
BUDESONIDE.5 mg/2mL

OpenFDA Data

SPL SET ID:e8ef9489-83a2-4817-b21c-ea3fecd8c8dd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351109
  • 349094

    • 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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