NDC 51862-582

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 ID: 51862-582_093ed8f6-90a8-4d13-8b95-0168493579e3
• NDC: 51862-582
• Product Type: Human Prescription Drug
• Proprietary Name: BUDESONIDE (ENTERIC COATED)
• Generic Name: Budesonide
• Dosage Form: Capsule, Delayed Release Pellets
• Route of Administration: ORAL
• Marketing Start Date: 2016-10-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206623
• Labeler Name: Mayne Pharma Inc.
• Substance Name: BUDESONIDE
• Active Ingredient Strength: 3 mg/1
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 51862-582-01

100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51862-582-01)

• Marketing Start Date: 2016-10-25
• Marketing End Date: 2021-06-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51862-582-01 [51862058201]

BUDESONIDE (ENTERIC COATED) CAPSULE, DELAYED RELEASE PELLETS

• Marketing Category: ANDA
• Application Number: ANDA206623
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-10-25
• Marketing End Date: 2021-06-30

Drug Details

Active Ingredients

Ingredient	Strength
BUDESONIDE	3 mg/1

OpenFDA Data

• SPL SET ID: 7ab5e7bc-7962-4b6a-8647-40f635df1e77
• Manufacturer:
  • Mayne Pharma Inc.
• UNII:
  • Q3OKS62Q6X
• RxNorm Concept Unique ID - RxCUI:
  • 1244214

Pharmacological Class

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

Medicade Reported Pricing

51862058201 BUDESONIDE EC 3 MG CAPSULE

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
47781-146	Budesonide (enteric coated)	Budesonide (enteric coated)
51862-582	BUDESONIDE (ENTERIC COATED)	BUDESONIDE (ENTERIC COATED)
55700-590	BUDESONIDE (ENTERIC COATED)	BUDESONIDE (ENTERIC COATED)
51862-580	BUDESONIDE (ENTERIC COATED)	BUDESONIDE (ENTERIC COATED)
0093-6815	Budesonide	Budesonide
0093-6816	Budesonide	Budesonide
0093-6817	Budesonide	Budesonide
0093-7445	Budesonide	Budesonide
0115-1687	Budesonide Inhalation	Budesonide
0115-1689	Budesonide Inhalation	Budesonide
0186-0916	PULMICORT	Budesonide
0186-0917	PULMICORT	Budesonide
0186-1988	PULMICORT RESPULES	Budesonide
0186-1989	PULMICORT RESPULES	Budesonide
0186-1990	PULMICORT RESPULES	Budesonide