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 801 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2466
Product ID 72162-2466_1b6d782c-c1a3-42fd-97a2-37b4a6cf7334
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 721622466
Hyphenated Format 72162-2466

Supplemental Identifiers

RxCUI
1868018
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
  • 801 mg/1
source: ndc
Packaging
  • 90 TABLET, COATED in 1 BOTTLE (72162-2466-9)
source: ndc

Packages (1)

72162-2466-9 90 TABLET, COATED in 1 BOTTLE (72162-2466-9)

Ingredients (1)

pirfenidone (801 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": "1b6d782c-c1a3-42fd-97a2-37b4a6cf7334", "openfda": {"nui": ["N0000191420", "M0018236"], "unii": ["D7NLD2JX7U"], "rxcui": ["1868018"], "spl_set_id": ["bfcb3157-cfa1-493d-9598-1e7fd3d355d9"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (72162-2466-9)", "package_ndc": "72162-2466-9", "marketing_start_date": "20250306"}], "brand_name": "Pirfenidone", "product_id": "72162-2466_1b6d782c-c1a3-42fd-97a2-37b4a6cf7334", "dosage_form": "TABLET, COATED", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "72162-2466", "generic_name": "Pirfenidone", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pirfenidone", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "801 mg/1"}], "application_number": "ANDA212708", "marketing_category": "ANDA", "marketing_start_date": "20220610", "listing_expiration_date": "20261231"}