pirfenidone

Generic: pirfenidone

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pirfenidone
Generic Name pirfenidone
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

pirfenidone 267 mg/1

Manufacturer
MAJOR PHARMACEUTICALS

Identifiers & Regulatory

Product NDC 0904-7397
Product ID 0904-7397_73db516f-8c80-431f-8190-33081718cf8d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212772
Listing Expiration 2026-12-31
Marketing Start 2022-05-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047397
Hyphenated Format 0904-7397

Supplemental Identifiers

RxCUI
1868014 1868018
UPC
0309047398898 0309047397532 0309047397891
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 ANDA212772 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 267 mg/1
source: ndc
Packaging
  • 3 BOTTLE in 1 CARTON (0904-7397-53) / 90 TABLET, FILM COATED in 1 BOTTLE (0904-7397-89)
source: ndc

Packages (1)

0904-7397-53 3 BOTTLE in 1 CARTON (0904-7397-53) / 90 TABLET, FILM COATED in 1 BOTTLE (0904-7397-89)

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": "73db516f-8c80-431f-8190-33081718cf8d", "openfda": {"nui": ["N0000191420", "M0018236"], "upc": ["0309047398898", "0309047397532", "0309047397891"], "unii": ["D7NLD2JX7U"], "rxcui": ["1868014", "1868018"], "spl_set_id": ["73db516f-8c80-431f-8190-33081718cf8d"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["MAJOR PHARMACEUTICALS"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (0904-7397-53)  / 90 TABLET, FILM COATED in 1 BOTTLE (0904-7397-89)", "package_ndc": "0904-7397-53", "marketing_start_date": "20240302"}], "brand_name": "PIRFENIDONE", "product_id": "0904-7397_73db516f-8c80-431f-8190-33081718cf8d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "0904-7397", "generic_name": "PIRFENIDONE", "labeler_name": "MAJOR PHARMACEUTICALS", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PIRFENIDONE", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "267 mg/1"}], "application_number": "ANDA212772", "marketing_category": "ANDA", "marketing_start_date": "20220524", "listing_expiration_date": "20261231"}