NDC 0093-6817

Budesonide

Budesonide

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

Product ID0093-6817_1b4133f8-fdd4-4f4e-92d5-f6b90be2c6d5
NDC0093-6817
Product TypeHuman Prescription Drug
Proprietary NameBudesonide
Generic NameBudesonide
Dosage FormSuspension
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2016-03-11
Marketing CategoryANDA / ANDA
Application NumberANDA204548
Labeler NameTeva Pharmaceuticals 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 0093-6817-73

6 POUCH in 1 CARTON (0093-6817-73) > 5 AMPULE in 1 POUCH (0093-6817-45) > 2 mL in 1 AMPULE (0093-6817-19)
Marketing Start Date2016-03-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-6817-45 [00093681745]

Budesonide SUSPENSION
Marketing CategoryANDA
Application NumberANDA204548
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-03-11

NDC 0093-6817-19 [00093681719]

Budesonide SUSPENSION
Marketing CategoryANDA
Application NumberANDA204548
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-08-03

NDC 0093-6817-73 [00093681773]

Budesonide SUSPENSION
Marketing CategoryANDA
Application NumberANDA204548
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-03-11

Drug Details

Active Ingredients

IngredientStrength
BUDESONIDE1 mg/2mL

OpenFDA Data

SPL SET ID:d90ffda1-12c7-4726-90e9-64bb103e84b5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 252559

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0093-6815BudesonideBudesonide
    0093-6816BudesonideBudesonide
    0093-6817BudesonideBudesonide
    0093-7445BudesonideBudesonide
    68151-4374BudesonideBudesonide
    68258-8922BudesonideBudesonide
    68382-720budesonidebudesonide
    0487-9601BudesonideBudesonide
    0487-9701BudesonideBudesonide
    68788-0012BudesonideBudesonide
    68682-309budesonidebudesonide
    68788-6873BudesonideBudesonide
    68788-0013BudesonideBudesonide
    68788-6796BudesonideBudesonide
    68788-7020BudesonideBudesonide
    0536-1112BudesonideBudesonide
    69842-001BudesonideBudesonide
    0574-9855budesonidebudesonide
    0591-2510BudesonideBudesonide
    70771-1075budesonidebudesonide
    0781-7517BudesonideBudesonide
    0781-7515BudesonideBudesonide
    0781-7516BudesonideBudesonide
    11822-6000BudesonideBudesonide
    16714-829budesonidebudesonide
    21130-710BudesonideBudesonide
    36800-113BudesonideBudesonide
    46122-389BudesonideBudesonide
    49035-703BudesonideBudesonide
    51079-020BudesonideBudesonide
    0363-0048BudesonideBudesonide
    60505-6194BudesonideBudesonide
    60429-264BudesonideBudesonide
    60505-0820BUDESONIDEBUDESONIDE
    60505-0821BUDESONIDEBUDESONIDE
    60505-6129BudesonideBudesonide
    60687-421BudesonideBudesonide
    64980-255BudesonideBudesonide
    0378-7155BudesonideBudesonide
    65162-778BudesonideBudesonide
    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.