pirfenidone

Generic: pirfenidone

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

pirfenidone 267 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-181
Product ID 72205-181_2e84fe0d-424b-472b-938a-ef317ed61a79
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212772
Listing Expiration 2026-12-31
Marketing Start 2022-09-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72205181
Hyphenated Format 72205-181

Supplemental Identifiers

RxCUI
1868014 1868018
UPC
0372205181304 0372205182905 0372205181267 0372205181908 0372205182301
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 (72205-181-26) / 90 TABLET, FILM COATED in 1 BOTTLE (72205-181-90)
  • 3 BOTTLE in 1 CARTON (72205-181-36) / 30 TABLET, FILM COATED in 1 BOTTLE (72205-181-30)
  • 9 BOTTLE in 1 CARTON (72205-181-38) / 30 TABLET, FILM COATED in 1 BOTTLE (72205-181-30)
source: ndc

Packages (3)

72205-181-26 3 BOTTLE in 1 CARTON (72205-181-26) / 90 TABLET, FILM COATED in 1 BOTTLE (72205-181-90) 72205-181-36 3 BOTTLE in 1 CARTON (72205-181-36) / 30 TABLET, FILM COATED in 1 BOTTLE (72205-181-30) 72205-181-38 9 BOTTLE in 1 CARTON (72205-181-38) / 30 TABLET, FILM COATED in 1 BOTTLE (72205-181-30)

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": "2e84fe0d-424b-472b-938a-ef317ed61a79", "openfda": {"nui": ["N0000191420", "M0018236"], "upc": ["0372205181304", "0372205182905", "0372205181267", "0372205181908", "0372205182301"], "unii": ["D7NLD2JX7U"], "rxcui": ["1868014", "1868018"], "spl_set_id": ["741d1b9c-e281-4eca-b327-e25e82313006"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (72205-181-26)  / 90 TABLET, FILM COATED in 1 BOTTLE (72205-181-90)", "package_ndc": "72205-181-26", "marketing_start_date": "20220908"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (72205-181-36)  / 30 TABLET, FILM COATED in 1 BOTTLE (72205-181-30)", "package_ndc": "72205-181-36", "marketing_start_date": "20220908"}, {"sample": false, "description": "9 BOTTLE in 1 CARTON (72205-181-38)  / 30 TABLET, FILM COATED in 1 BOTTLE (72205-181-30)", "package_ndc": "72205-181-38", "marketing_start_date": "20220908"}], "brand_name": "PIRFENIDONE", "product_id": "72205-181_2e84fe0d-424b-472b-938a-ef317ed61a79", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "72205-181", "generic_name": "PIRFENIDONE", "labeler_name": "Novadoz Pharmaceuticals LLC", "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": "20220907", "listing_expiration_date": "20261231"}