pirfenidone

Generic: pirfenidone

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

Drug Facts

Product Profile

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

pirfenidone 801 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1641
Product ID 69238-1641_08b2264e-d081-4558-9893-0a11d25e7a39
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212570
Listing Expiration 2026-12-31
Marketing Start 2023-02-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692381641
Hyphenated Format 69238-1641

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
  • 801 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (69238-1641-9) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

69238-1641-9 1 BOTTLE, PLASTIC in 1 CARTON (69238-1641-9) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

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": "08b2264e-d081-4558-9893-0a11d25e7a39", "openfda": {"nui": ["N0000191420", "M0018236"], "unii": ["D7NLD2JX7U"], "rxcui": ["1868014", "1868018"], "spl_set_id": ["a235768d-d26d-4ded-ae75-53e93310ff6a"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (69238-1641-9)  / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "69238-1641-9", "marketing_start_date": "20230228"}], "brand_name": "Pirfenidone", "product_id": "69238-1641_08b2264e-d081-4558-9893-0a11d25e7a39", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "69238-1641", "generic_name": "Pirfenidone", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pirfenidone", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "801 mg/1"}], "application_number": "ANDA212570", "marketing_category": "ANDA", "marketing_start_date": "20230228", "listing_expiration_date": "20261231"}