pirfenidone

Generic: pirfenidone

Labeler: sciegen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pirfenidone
Generic Name pirfenidone
Labeler sciegen pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pirfenidone 267 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50228-442
Product ID 50228-442_09af4fec-e2cf-2c8d-e063-6294a90af999
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212078
Listing Expiration 2026-12-31
Marketing Start 2022-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228442
Hyphenated Format 50228-442

Supplemental Identifiers

RxCUI
1868014 1868018
UPC
0350228443302 0350228442305
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 ANDA212078 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 267 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (50228-442-10)
  • 30 TABLET in 1 BOTTLE (50228-442-30)
source: ndc

Packages (2)

50228-442-10 1000 TABLET in 1 BOTTLE (50228-442-10) 50228-442-30 30 TABLET in 1 BOTTLE (50228-442-30)

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": "09af4fec-e2cf-2c8d-e063-6294a90af999", "openfda": {"nui": ["N0000191420", "M0018236"], "upc": ["0350228443302", "0350228442305"], "unii": ["D7NLD2JX7U"], "rxcui": ["1868014", "1868018"], "spl_set_id": ["155b948e-47f5-4741-8e82-2ed65ccfab7d"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (50228-442-10)", "package_ndc": "50228-442-10", "marketing_start_date": "20220801"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50228-442-30)", "package_ndc": "50228-442-30", "marketing_start_date": "20220801"}], "brand_name": "PIRFENIDONE", "product_id": "50228-442_09af4fec-e2cf-2c8d-e063-6294a90af999", "dosage_form": "TABLET", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "50228-442", "generic_name": "PIRFENIDONE", "labeler_name": "ScieGen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PIRFENIDONE", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "267 mg/1"}], "application_number": "ANDA212078", "marketing_category": "ANDA", "marketing_start_date": "20220801", "listing_expiration_date": "20261231"}