pirfenidone

Generic: pirfenidone

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pirfenidone
Generic Name pirfenidone
Labeler bryant ranch prepack
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

pirfenidone 267 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2465
Product ID 72162-2465_83800d33-deb2-4159-8a64-8758f9f5aac7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212708
Listing Expiration 2026-12-31
Marketing Start 2022-06-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 721622465
Hyphenated Format 72162-2465

Supplemental Identifiers

RxCUI
1868014
UNII
D7NLD2JX7U
NUI
N0000191420 M0018236

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 pirfenidone (source: ndc)
Generic Name pirfenidone (source: ndc)
Application Number ANDA212708 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 267 mg/1
source: ndc
Packaging
  • 3 BOTTLE in 1 CARTON (72162-2465-2) / 90 TABLET, COATED in 1 BOTTLE
  • 270 TABLET, COATED in 1 BOTTLE (72162-2465-4)
  • 90 TABLET, COATED in 1 BOTTLE (72162-2465-9)
source: ndc

Packages (3)

72162-2465-2 3 BOTTLE in 1 CARTON (72162-2465-2) / 90 TABLET, COATED in 1 BOTTLE 72162-2465-4 270 TABLET, COATED in 1 BOTTLE (72162-2465-4) 72162-2465-9 90 TABLET, COATED in 1 BOTTLE (72162-2465-9)

Ingredients (1)

pirfenidone (267 mg/1)

Linked Drug Pages (1)

Pirfenidone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "83800d33-deb2-4159-8a64-8758f9f5aac7", "openfda": {"nui": ["N0000191420", "M0018236"], "unii": ["D7NLD2JX7U"], "rxcui": ["1868014"], "spl_set_id": ["9bdc7ed9-e51c-4101-a792-31619f05136b"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (72162-2465-2)  / 90 TABLET, COATED in 1 BOTTLE", "package_ndc": "72162-2465-2", "marketing_start_date": "20250306"}, {"sample": false, "description": "270 TABLET, COATED in 1 BOTTLE (72162-2465-4)", "package_ndc": "72162-2465-4", "marketing_start_date": "20250514"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (72162-2465-9)", "package_ndc": "72162-2465-9", "marketing_start_date": "20250514"}], "brand_name": "Pirfenidone", "product_id": "72162-2465_83800d33-deb2-4159-8a64-8758f9f5aac7", "dosage_form": "TABLET, COATED", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "72162-2465", "generic_name": "Pirfenidone", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pirfenidone", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "267 mg/1"}], "application_number": "ANDA212708", "marketing_category": "ANDA", "marketing_start_date": "20220610", "listing_expiration_date": "20261231"}