pirfenidone

Generic: pirfenidone

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

Drug Facts

Product Profile

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

pirfenidone 267 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-3610
Product ID 0480-3610_eb41bb72-1c2a-4c39-80a6-c09f3bf897fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212759
Listing Expiration 2026-12-31
Marketing Start 2022-05-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04803610
Hyphenated Format 0480-3610

Supplemental Identifiers

RxCUI
1868014 1868018
UPC
0304803611983 0304803610870
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 ANDA212759 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 267 mg/1
source: ndc
Packaging
  • 270 TABLET, FILM COATED in 1 BOTTLE (0480-3610-87)
source: ndc

Packages (1)

0480-3610-87 270 TABLET, FILM COATED in 1 BOTTLE (0480-3610-87)

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": "eb41bb72-1c2a-4c39-80a6-c09f3bf897fb", "openfda": {"nui": ["N0000191420", "M0018236"], "upc": ["0304803611983", "0304803610870"], "unii": ["D7NLD2JX7U"], "rxcui": ["1868014", "1868018"], "spl_set_id": ["cbbd14a4-b7e6-4147-9314-bb715dfb1a51"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "270 TABLET, FILM COATED in 1 BOTTLE (0480-3610-87)", "package_ndc": "0480-3610-87", "marketing_start_date": "20220511"}], "brand_name": "Pirfenidone", "product_id": "0480-3610_eb41bb72-1c2a-4c39-80a6-c09f3bf897fb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "0480-3610", "generic_name": "Pirfenidone", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pirfenidone", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "267 mg/1"}], "application_number": "ANDA212759", "marketing_category": "ANDA", "marketing_start_date": "20220511", "listing_expiration_date": "20261231"}