NDC 69097-321

Budesonide Inhalation Suspension

Budesonide

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

Product ID69097-321_1e24945e-9d23-400b-9964-af4af5309b14
NDC69097-321
Product TypeHuman Prescription Drug
Proprietary NameBudesonide Inhalation Suspension
Generic NameBudesonide
Dosage FormInhalant
Route of AdministrationORAL
Marketing Start Date2017-11-16
Marketing CategoryANDA / ANDA
Application NumberANDA205710
Labeler NameCipla USA 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 69097-321-53

30 POUCH in 1 CARTON (69097-321-53) > 1 AMPULE in 1 POUCH (69097-321-32) > 2 mL in 1 AMPULE
Marketing Start Date2020-04-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69097-321-86 [69097032186]

Budesonide Inhalation Suspension INHALANT
Marketing CategoryANDA
Application NumberANDA205710
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-11-16

NDC 69097-321-32 [69097032132]

Budesonide Inhalation Suspension INHALANT
Marketing CategoryANDA
Application NumberANDA205710
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-13

NDC 69097-321-87 [69097032187]

Budesonide Inhalation Suspension INHALANT
Marketing CategoryANDA
Application NumberANDA205710
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-11-16

NDC 69097-321-53 [69097032153]

Budesonide Inhalation Suspension INHALANT
Marketing CategoryANDA
Application NumberANDA205710
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-10

Drug Details

Active Ingredients

IngredientStrength
BUDESONIDE1 mg/2mL

OpenFDA Data

SPL SET ID:c52c5382-1400-44b9-95be-a30e1cf706da
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351109
  • 252559
  • 349094

    • Pharmacological Class

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

    Medicade Reported Pricing

    69097032187 BUDESONIDE 1 MG/2 ML INH SUSP

    Pricing Unit: ML | Drug Type:

    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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.