pirfenidone

Generic: pirfenidone

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

pirfenidone 267 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-491
Product ID 42291-491_485f7ae5-a12f-d7a7-e063-6294a90a75cd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212570
Listing Expiration 2027-12-31
Marketing Start 2023-10-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291491
Hyphenated Format 42291-491

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 ANDA212570 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 267 mg/1
source: ndc
Packaging
  • 3 BOTTLE in 1 CARTON (42291-491-27) / 90 TABLET, FILM COATED in 1 BOTTLE (42291-491-09)
source: ndc

Packages (1)

42291-491-27 3 BOTTLE in 1 CARTON (42291-491-27) / 90 TABLET, FILM COATED in 1 BOTTLE (42291-491-09)

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": "485f7ae5-a12f-d7a7-e063-6294a90a75cd", "openfda": {"nui": ["N0000191420", "M0018236"], "unii": ["D7NLD2JX7U"], "rxcui": ["1868014", "1868018"], "spl_set_id": ["08046b49-a8b3-a78d-e063-6394a90a80fa"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["AvKARE"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (42291-491-27)  / 90 TABLET, FILM COATED in 1 BOTTLE (42291-491-09)", "package_ndc": "42291-491-27", "marketing_start_date": "20231018"}], "brand_name": "Pirfenidone", "product_id": "42291-491_485f7ae5-a12f-d7a7-e063-6294a90a75cd", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "42291-491", "generic_name": "Pirfenidone", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pirfenidone", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "267 mg/1"}], "application_number": "ANDA212570", "marketing_category": "ANDA", "marketing_start_date": "20231018", "listing_expiration_date": "20271231"}