NDC 0574-9850

Entocort EC

Budesonide

Entocort EC is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Paddock Laboratories, Llc. The primary component is Budesonide.

Product ID0574-9850_00c8d2ff-9394-44f9-8cb5-3a420cb44e60
NDC0574-9850
Product TypeHuman Prescription Drug
Proprietary NameEntocort EC
Generic NameBudesonide
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2001-10-29
Marketing CategoryNDA / NDA
Application NumberNDA021324
Labeler NamePaddock Laboratories, 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 0574-9850-10

100 CAPSULE in 1 BOTTLE (0574-9850-10)
Marketing Start Date2001-10-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0574-9850-10 [00574985010]

Entocort EC CAPSULE
Marketing CategoryNDA
Application NumberNDA021324
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-10-29

Drug Details

Active Ingredients

IngredientStrength
BUDESONIDE3 mg/1

OpenFDA Data

SPL SET ID:24f0312f-f768-42db-bf7c-4ba2ee4fc309
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1244215
  • 1244214
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0574-9850Entocort ECEntocort EC
    65483-702ENTOCORT ECENTOCORT EC
    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

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