NDC 0378-7155

Budesonide

Budesonide

Budesonide is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Budesonide.

Product ID0378-7155_282aca47-6fd0-463b-b3d8-af14fe637978
NDC0378-7155
Product TypeHuman Prescription Drug
Proprietary NameBudesonide
Generic NameBudesonide
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2011-05-16
Marketing CategoryANDA / ANDA
Application NumberANDA090410
Labeler NameMylan Pharmaceuticals Inc.
Substance NameBUDESONIDE
Active Ingredient Strength3 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-7155-01

100 CAPSULE in 1 BOTTLE, PLASTIC (0378-7155-01)
Marketing Start Date2011-05-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-7155-05 [00378715505]

Budesonide CAPSULE
Marketing CategoryANDA
Application NumberANDA090410
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-05-16
Marketing End Date2018-01-24

NDC 0378-7155-01 [00378715501]

Budesonide CAPSULE
Marketing CategoryANDA
Application NumberANDA090410
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-05-16

Drug Details

Active Ingredients

IngredientStrength
BUDESONIDE3 mg/1

OpenFDA Data

SPL SET ID:4a578d93-087e-42f7-a258-a49afef41dea
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1244214
  • Pharmacological Class

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

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