pirfenidone

Generic: pirfenidone

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pirfenidone
Generic Name pirfenidone
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pirfenidone 801 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-239
Product ID 59651-239_50958060-c904-4374-997d-59df54007fa4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212596
Listing Expiration 2026-12-31
Marketing Start 2025-08-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651239
Hyphenated Format 59651-239

Supplemental Identifiers

RxCUI
1868014 1868018
UPC
0359651239902
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 pirfenidone (source: ndc)
Generic Name pirfenidone (source: ndc)
Application Number ANDA212596 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 801 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (59651-239-90) / 90 TABLET in 1 BOTTLE
source: ndc

Packages (1)

59651-239-90 1 BOTTLE in 1 CARTON (59651-239-90) / 90 TABLET in 1 BOTTLE

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": "50958060-c904-4374-997d-59df54007fa4", "openfda": {"nui": ["N0000191420", "M0018236"], "upc": ["0359651239902"], "unii": ["D7NLD2JX7U"], "rxcui": ["1868014", "1868018"], "spl_set_id": ["50958060-c904-4374-997d-59df54007fa4"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (59651-239-90)  / 90 TABLET in 1 BOTTLE", "package_ndc": "59651-239-90", "marketing_start_date": "20250811"}], "brand_name": "Pirfenidone", "product_id": "59651-239_50958060-c904-4374-997d-59df54007fa4", "dosage_form": "TABLET", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "59651-239", "generic_name": "Pirfenidone", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pirfenidone", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "801 mg/1"}], "application_number": "ANDA212596", "marketing_category": "ANDA", "marketing_start_date": "20250811", "listing_expiration_date": "20261231"}