NDC 51862-580

BUDESONIDE (ENTERIC COATED)

Budesonide

BUDESONIDE (ENTERIC COATED) is a Oral Capsule, Delayed Release Pellets in the Human Prescription Drug category. It is labeled and distributed by Mayne Pharma Inc.. The primary component is Budesonide.

Product ID51862-580_6f52d255-0a89-4ad9-abb2-5ae54e76ecdd
NDC51862-580
Product TypeHuman Prescription Drug
Proprietary NameBUDESONIDE (ENTERIC COATED)
Generic NameBudesonide
Dosage FormCapsule, Delayed Release Pellets
Route of AdministrationORAL
Marketing Start Date2019-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA206623
Labeler NameMayne Pharma 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 51862-580-01

100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51862-580-01)
Marketing Start Date2019-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51862-580-01 [51862058001]

BUDESONIDE (ENTERIC COATED) CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA206623
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-10-31

Drug Details

Active Ingredients

IngredientStrength
BUDESONIDE3 mg/1

Pharmacological Class

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

NDC Crossover Matching brand name "BUDESONIDE (ENTERIC COATED)" or generic name "Budesonide"

NDCBrand NameGeneric Name
47781-146Budesonide (enteric coated)Budesonide (enteric coated)
51862-582BUDESONIDE (ENTERIC COATED)BUDESONIDE (ENTERIC COATED)
55700-590BUDESONIDE (ENTERIC COATED)BUDESONIDE (ENTERIC COATED)
51862-580BUDESONIDE (ENTERIC COATED)BUDESONIDE (ENTERIC COATED)
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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