NDC 65162-778

Budesonide

Budesonide

Budesonide is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Budesonide.

Product ID65162-778_191b4ee3-1342-42aa-93b7-c08e9bed041d
NDC65162-778
Product TypeHuman Prescription Drug
Proprietary NameBudesonide
Generic NameBudesonide
Dosage FormCapsule, Gelatin Coated
Route of AdministrationORAL
Marketing Start Date2017-09-15
Marketing CategoryANDA / ANDA
Application NumberANDA206200
Labeler NameAmneal Pharmaceuticals LLC
Substance NameBUDESONIDE
Active Ingredient Strength3 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 65162-778-10

100 CAPSULE, GELATIN COATED in 1 BOTTLE (65162-778-10)
Marketing Start Date2017-09-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-778-10 [65162077810]

Budesonide CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA206200
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-09-15

NDC 65162-778-30 [65162077830]

Budesonide CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA206200
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-15

NDC 65162-778-49 [65162077849]

Budesonide CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA206200
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-15

NDC 65162-778-18 [65162077818]

Budesonide CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA206200
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-15

Drug Details

Active Ingredients

IngredientStrength
BUDESONIDE3 mg/1

OpenFDA Data

SPL SET ID:b15102d5-7884-44ed-8340-046d7b516fa8
Manufacturer
UNII
UPC Code
  • 0365162778304

    • Pharmacological Class

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

    Medicade Reported Pricing

    65162077810 BUDESONIDE EC 3 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    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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