budesonide

Generic: budesonide

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler major pharmaceuticals
Dosage Form CAPSULE, COATED PELLETS
Routes
ORAL
Active Ingredients

budesonide 3 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7313
Product ID 0904-7313_cb9e8049-c3d3-466e-bf9c-3c5032030f4e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206134
Listing Expiration 2026-12-31
Marketing Start 2024-09-03

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 09047313
Hyphenated Format 0904-7313

Supplemental Identifiers

RxCUI
1244214
UNII
Q3OKS62Q6X
NUI
N0000175576 N0000175450

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 ANDA206134 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 CARTON (0904-7313-10) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7313-10 20 BLISTER PACK in 1 CARTON (0904-7313-10) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK

Ingredients (1)

budesonide (3 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": "cb9e8049-c3d3-466e-bf9c-3c5032030f4e", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["1244214"], "spl_set_id": ["e7aca8d1-159e-4aac-b92d-3a69a8edceec"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 CARTON (0904-7313-10)  / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK", "package_ndc": "0904-7313-10", "marketing_start_date": "20240903"}], "brand_name": "budesonide", "product_id": "0904-7313_cb9e8049-c3d3-466e-bf9c-3c5032030f4e", "dosage_form": "CAPSULE, COATED PELLETS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0904-7313", "generic_name": "budesonide", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "budesonide", "active_ingredients": [{"name": "BUDESONIDE", "strength": "3 mg/1"}], "application_number": "ANDA206134", "marketing_category": "ANDA", "marketing_start_date": "20240903", "listing_expiration_date": "20261231"}