NDC 68180-984

budesonide inhalation

Budesonide Inhalation

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

Product ID68180-984_0976f1d7-c5a8-4d08-a96b-4ea17ddf5ace
NDC68180-984
Product TypeHuman Prescription Drug
Proprietary Namebudesonide inhalation
Generic NameBudesonide Inhalation
Dosage FormSuspension
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2019-05-21
Marketing CategoryANDA / ANDA
Application NumberANDA210897
Labeler NameLupin Pharmaceuticals, Inc.
Substance NameBUDESONIDE
Active Ingredient Strength1 mg/2mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68180-984-30

6 POUCH in 1 CARTON (68180-984-30) > 5 AMPULE in 1 POUCH (68180-984-05) > 2 mL in 1 AMPULE
Marketing Start Date2019-05-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68180-984-05 [68180098405]

budesonide inhalation SUSPENSION
Marketing CategoryANDA
Application NumberANDA210897
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-21

NDC 68180-984-30 [68180098430]

budesonide inhalation SUSPENSION
Marketing CategoryANDA
Application NumberANDA210897
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-21

Drug Details

Active Ingredients

IngredientStrength
BUDESONIDE.5 mg/2mL

OpenFDA Data

SPL SET ID:944cbb7c-b41d-4a6d-8a93-2e646365c982
Manufacturer
UNII
UPC Code
  • 0368180984054

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0115-1687Budesonide InhalationBudesonide
    0115-1689Budesonide InhalationBudesonide
    60687-524Budesonide InhalationBudesonide Inhalation
    65302-042Budesonide InhalationBudesonide Inhalation Suspension
    68180-984budesonide inhalationbudesonide inhalation
    68788-3768Budesonide InhalationBudesonide
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