esbriet

Generic: pirfenidone

Labeler: legacy pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name esbriet
Generic Name pirfenidone
Labeler legacy pharma usa inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

pirfenidone 801 mg/1

Manufacturer
Legacy Pharma USA Inc.

Identifiers & Regulatory

Product NDC 83107-029
Product ID 83107-029_372827fa-ccfe-42b6-e063-6394a90af5e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208780
Listing Expiration 2026-12-31
Marketing Start 2025-05-31

Pharmacologic Class

Established (EPC)
pyridone [epc]
Chemical Structure
pyridones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83107029
Hyphenated Format 83107-029

Supplemental Identifiers

RxCUI
1868014 1868016 1868018 1868020
UNII
D7NLD2JX7U
NUI
N0000191420 M0018236

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 esbriet (source: ndc)
Generic Name pirfenidone (source: ndc)
Application Number NDA208780 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 801 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (83107-029-90) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

83107-029-90 1 BOTTLE, PLASTIC in 1 CARTON (83107-029-90) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC

Ingredients (1)

pirfenidone (801 mg/1)

Linked Drug Pages (1)

ESBRIET ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "372827fa-ccfe-42b6-e063-6394a90af5e8", "openfda": {"nui": ["N0000191420", "M0018236"], "unii": ["D7NLD2JX7U"], "rxcui": ["1868014", "1868016", "1868018", "1868020"], "spl_set_id": ["81f17f7d-cb04-4052-8682-dd3e330210ab"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["Legacy Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (83107-029-90)  / 90 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "83107-029-90", "marketing_start_date": "20250604"}], "brand_name": "ESBRIET", "product_id": "83107-029_372827fa-ccfe-42b6-e063-6394a90af5e8", "dosage_form": "TABLET, COATED", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "83107-029", "generic_name": "PIRFENIDONE", "labeler_name": "Legacy Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ESBRIET", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "801 mg/1"}], "application_number": "NDA208780", "marketing_category": "NDA", "marketing_start_date": "20250531", "listing_expiration_date": "20261231"}