pirfenidone

Generic: pirfenidone

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pirfenidone
Generic Name pirfenidone
Labeler accord healthcare inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

pirfenidone 267 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-467
Product ID 16729-467_462905a9-67d0-513b-e063-6294a90aa9b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212730
Listing Expiration 2026-12-31
Marketing Start 2022-05-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729467
Hyphenated Format 16729-467

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 ANDA212730 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 267 mg/1
source: ndc
Packaging
  • 3 BOTTLE, PLASTIC in 1 CARTON (16729-467-85) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-467-15)
source: ndc

Packages (1)

16729-467-85 3 BOTTLE, PLASTIC in 1 CARTON (16729-467-85) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-467-15)

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": "462905a9-67d0-513b-e063-6294a90aa9b4", "openfda": {"nui": ["N0000191420", "M0018236"], "unii": ["D7NLD2JX7U"], "rxcui": ["1868014", "1868018"], "spl_set_id": ["fab59395-1c5d-4c64-ba47-34d75736e983"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE, PLASTIC in 1 CARTON (16729-467-85)  / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-467-15)", "package_ndc": "16729-467-85", "marketing_start_date": "20220527"}], "brand_name": "PIRFENIDONE", "product_id": "16729-467_462905a9-67d0-513b-e063-6294a90aa9b4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "16729-467", "generic_name": "PIRFENIDONE", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PIRFENIDONE", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "267 mg/1"}], "application_number": "ANDA212730", "marketing_category": "ANDA", "marketing_start_date": "20220527", "listing_expiration_date": "20261231"}