pirfenidone

Generic: pirfenidone

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pirfenidone
Generic Name pirfenidone
Labeler apotex corp.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pirfenidone 801 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-4682
Product ID 60505-4682_21373a74-fff2-88e4-8a1c-973d94fa05dc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212709
Listing Expiration 2026-12-31
Marketing Start 2024-04-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605054682
Hyphenated Format 60505-4682

Supplemental Identifiers

RxCUI
1868014 1868018
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 ANDA212709 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 801 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (60505-4682-9)
source: ndc

Packages (1)

60505-4682-9 90 TABLET in 1 BOTTLE (60505-4682-9)

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": "21373a74-fff2-88e4-8a1c-973d94fa05dc", "openfda": {"nui": ["N0000191420", "M0018236"], "unii": ["D7NLD2JX7U"], "rxcui": ["1868014", "1868018"], "spl_set_id": ["9ccfe91e-d1fc-d4c1-115b-dd7859b2c3e6"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (60505-4682-9)", "package_ndc": "60505-4682-9", "marketing_start_date": "20240409"}], "brand_name": "Pirfenidone", "product_id": "60505-4682_21373a74-fff2-88e4-8a1c-973d94fa05dc", "dosage_form": "TABLET", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "60505-4682", "generic_name": "Pirfenidone", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pirfenidone", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "801 mg/1"}], "application_number": "ANDA212709", "marketing_category": "ANDA", "marketing_start_date": "20240409", "listing_expiration_date": "20261231"}