esbriet

Generic: pirfenidone

Labeler: genentech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

pirfenidone 267 mg/1

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-122
Product ID 50242-122_86848f3d-1ab2-457b-9f36-eba22bea36dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208780
Marketing Start 2017-01-11
Marketing End 2029-01-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242122
Hyphenated Format 50242-122

Supplemental Identifiers

RxCUI
1592279 1592285 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
  • 267 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (50242-122-06) / 270 TABLET, COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

50242-122-06 1 BOTTLE, PLASTIC in 1 CARTON (50242-122-06) / 270 TABLET, COATED in 1 BOTTLE, PLASTIC

Ingredients (1)

pirfenidone (267 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": "86848f3d-1ab2-457b-9f36-eba22bea36dd", "openfda": {"nui": ["N0000191420", "M0018236"], "unii": ["D7NLD2JX7U"], "rxcui": ["1592279", "1592285", "1868014", "1868016", "1868018", "1868020"], "spl_set_id": ["2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50242-122-06)  / 270 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50242-122-06", "marketing_end_date": "20290131", "marketing_start_date": "20180122"}], "brand_name": "ESBRIET", "product_id": "50242-122_86848f3d-1ab2-457b-9f36-eba22bea36dd", "dosage_form": "TABLET, COATED", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "50242-122", "generic_name": "PIRFENIDONE", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ESBRIET", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "267 mg/1"}], "application_number": "NDA208780", "marketing_category": "NDA", "marketing_end_date": "20290131", "marketing_start_date": "20170111"}