pirfenidone

Generic: pirfenidone

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

pirfenidone 801 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-8086
Product ID 0781-8086_b22f432a-14bf-44b2-bb86-63dc277ce7ed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212560
Listing Expiration 2026-12-31
Marketing Start 2022-05-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07818086
Hyphenated Format 0781-8086

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 ANDA212560 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 801 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0781-8086-92)
source: ndc

Packages (1)

0781-8086-92 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0781-8086-92)

Ingredients (1)

pirfenidone (801 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": "b22f432a-14bf-44b2-bb86-63dc277ce7ed", "openfda": {"nui": ["N0000191420", "M0018236"], "unii": ["D7NLD2JX7U"], "rxcui": ["1868014", "1868018"], "spl_set_id": ["7f5f7cc9-394e-4da0-87eb-84cfff9707a3"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0781-8086-92)", "package_ndc": "0781-8086-92", "marketing_start_date": "20220502"}], "brand_name": "Pirfenidone", "product_id": "0781-8086_b22f432a-14bf-44b2-bb86-63dc277ce7ed", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "0781-8086", "generic_name": "Pirfenidone", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pirfenidone", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "801 mg/1"}], "application_number": "ANDA212560", "marketing_category": "ANDA", "marketing_start_date": "20220502", "listing_expiration_date": "20261231"}