eohilia

Generic: budesonide

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name eohilia
Generic Name budesonide
Labeler takeda pharmaceuticals america, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

budesonide 2 mg/10mL

Manufacturer
TAKEDA PHARMACEUTICALS AMERICA, INC.

Identifiers & Regulatory

Product NDC 64764-105
Product ID 64764-105_6b8f012a-d7af-4200-a5b8-5a56f6962ccd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213976
Listing Expiration 2026-12-31
Marketing Start 2024-02-09

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 64764105
Hyphenated Format 64764-105

Supplemental Identifiers

RxCUI
2675280 2675286
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 eohilia (source: ndc)
Generic Name budesonide (source: ndc)
Application Number NDA213976 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/10mL
source: ndc
Packaging
  • 10 POUCH in 1 CARTON (64764-105-00) / 10 mL in 1 POUCH (64764-105-01)
  • 60 POUCH in 1 CARTON (64764-105-60) / 10 mL in 1 POUCH (64764-105-10)
source: ndc

Packages (2)

64764-105-00 10 POUCH in 1 CARTON (64764-105-00) / 10 mL in 1 POUCH (64764-105-01) 64764-105-60 60 POUCH in 1 CARTON (64764-105-60) / 10 mL in 1 POUCH (64764-105-10)

Ingredients (1)

budesonide (2 mg/10mL)

Linked Drug Pages (1)

Eohilia ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6b8f012a-d7af-4200-a5b8-5a56f6962ccd", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["2675280", "2675286"], "spl_set_id": ["56f2023a-69b2-4470-b4ad-af7ec1be527a"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["TAKEDA PHARMACEUTICALS AMERICA, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CARTON (64764-105-00)  / 10 mL in 1 POUCH (64764-105-01)", "package_ndc": "64764-105-00", "marketing_start_date": "20240209"}, {"sample": false, "description": "60 POUCH in 1 CARTON (64764-105-60)  / 10 mL in 1 POUCH (64764-105-10)", "package_ndc": "64764-105-60", "marketing_start_date": "20240209"}], "brand_name": "Eohilia", "product_id": "64764-105_6b8f012a-d7af-4200-a5b8-5a56f6962ccd", "dosage_form": "SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "64764-105", "generic_name": "Budesonide", "labeler_name": "TAKEDA PHARMACEUTICALS AMERICA, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eohilia", "active_ingredients": [{"name": "BUDESONIDE", "strength": "2 mg/10mL"}], "application_number": "NDA213976", "marketing_category": "NDA", "marketing_start_date": "20240209", "listing_expiration_date": "20261231"}