budesonide

Generic: budesonide

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

budesonide 9 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-4500
Product ID 0378-4500_812acf8d-0936-4ba9-9952-ae9f2266649b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208851
Listing Expiration 2026-12-31
Marketing Start 2020-10-21

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 03784500
Hyphenated Format 0378-4500

Supplemental Identifiers

RxCUI
1366550
UPC
0303784500934
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 (source: ndc)
Generic Name budesonide (source: ndc)
Application Number ANDA208851 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 9 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4500-93)
source: ndc

Packages (1)

0378-4500-93 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4500-93)

Ingredients (1)

budesonide (9 mg/1)

Linked Drug Pages (1)

Budesonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "812acf8d-0936-4ba9-9952-ae9f2266649b", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0303784500934"], "unii": ["Q3OKS62Q6X"], "rxcui": ["1366550"], "spl_set_id": ["f7265276-e649-4bc4-8ac8-1f5ac2b984e8"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4500-93)", "package_ndc": "0378-4500-93", "marketing_start_date": "20201021"}], "brand_name": "Budesonide", "product_id": "0378-4500_812acf8d-0936-4ba9-9952-ae9f2266649b", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0378-4500", "generic_name": "Budesonide", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Budesonide", "active_ingredients": [{"name": "BUDESONIDE", "strength": "9 mg/1"}], "application_number": "ANDA208851", "marketing_category": "ANDA", "marketing_start_date": "20201021", "listing_expiration_date": "20261231"}