pirfenidone

Generic: pirfenidone

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

Drug Facts

Product Profile

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

pirfenidone 267 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-869
Product ID 70954-869_fd354df5-de31-47d3-a67b-a45ad121153e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212722
Listing Expiration 2026-12-31
Marketing Start 2022-07-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954869
Hyphenated Format 70954-869

Supplemental Identifiers

RxCUI
1868014 1868018
UPC
0370954870104 0370954869306
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 ANDA212722 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 267 mg/1
source: ndc
Packaging
  • 3 BOTTLE in 1 CARTON (70954-869-10) / 90 TABLET, FILM COATED in 1 BOTTLE
  • 270 TABLET, FILM COATED in 1 BOTTLE (70954-869-30)
source: ndc

Packages (2)

70954-869-10 3 BOTTLE in 1 CARTON (70954-869-10) / 90 TABLET, FILM COATED in 1 BOTTLE 70954-869-30 270 TABLET, FILM COATED in 1 BOTTLE (70954-869-30)

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": "fd354df5-de31-47d3-a67b-a45ad121153e", "openfda": {"nui": ["N0000191420", "M0018236"], "upc": ["0370954870104", "0370954869306"], "unii": ["D7NLD2JX7U"], "rxcui": ["1868014", "1868018"], "spl_set_id": ["976620bb-c10e-4b13-8a97-7025fda6b7d5"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (70954-869-10)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "70954-869-10", "marketing_start_date": "20220719"}, {"sample": false, "description": "270 TABLET, FILM COATED in 1 BOTTLE (70954-869-30)", "package_ndc": "70954-869-30", "marketing_start_date": "20240228"}], "brand_name": "Pirfenidone", "product_id": "70954-869_fd354df5-de31-47d3-a67b-a45ad121153e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "70954-869", "generic_name": "Pirfenidone", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pirfenidone", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "267 mg/1"}], "application_number": "ANDA212722", "marketing_category": "ANDA", "marketing_start_date": "20220719", "listing_expiration_date": "20261231"}