budesonide (enteric coated)

Generic: budesonide

Labeler: mayne pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide (enteric coated)
Generic Name budesonide
Labeler mayne pharma inc.
Dosage Form CAPSULE, DELAYED RELEASE PELLETS
Routes
ORAL
Active Ingredients

budesonide 3 mg/1

Manufacturer
Mayne Pharma Inc.

Identifiers & Regulatory

Product NDC 51862-580
Product ID 51862-580_d9a1678d-e215-4bed-a484-317d658fbe11
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206623
Listing Expiration 2026-12-31
Marketing Start 2019-10-31

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51862580
Hyphenated Format 51862-580

Supplemental Identifiers

RxCUI
1244214
UNII
Q3OKS62Q6X
NUI
N0000175576 N0000175450

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name budesonide (enteric coated) (source: ndc)
Generic Name budesonide (source: ndc)
Application Number ANDA206623 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51862-580-01)
source: ndc

Packages (1)

51862-580-01 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51862-580-01)

Ingredients (1)

budesonide (3 mg/1)

Linked Drug Pages (1)

BUDESONIDE (ENTERIC COATED) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d9a1678d-e215-4bed-a484-317d658fbe11", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["1244214"], "spl_set_id": ["0659420e-e376-4b90-98bf-71af41c18676"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Mayne Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51862-580-01)", "package_ndc": "51862-580-01", "marketing_start_date": "20191031"}], "brand_name": "BUDESONIDE (ENTERIC COATED)", "product_id": "51862-580_d9a1678d-e215-4bed-a484-317d658fbe11", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "51862-580", "generic_name": "Budesonide", "labeler_name": "Mayne Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUDESONIDE (ENTERIC COATED)", "active_ingredients": [{"name": "BUDESONIDE", "strength": "3 mg/1"}], "application_number": "ANDA206623", "marketing_category": "ANDA", "marketing_start_date": "20191031", "listing_expiration_date": "20261231"}