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 CAPSULE
Routes
ORAL
Active Ingredients

pirfenidone 267 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1642
Product ID 69238-1642_d7214722-7cee-4a8a-9b9e-8955333a1146
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212569
Listing Expiration 2026-12-31
Marketing Start 2022-01-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692381642
Hyphenated Format 69238-1642

Supplemental Identifiers

RxCUI
1592279
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 ANDA212569 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 267 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69238-1642-7) / 270 CAPSULE in 1 BOTTLE
source: ndc

Packages (1)

69238-1642-7 1 BOTTLE in 1 CARTON (69238-1642-7) / 270 CAPSULE in 1 BOTTLE

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": "d7214722-7cee-4a8a-9b9e-8955333a1146", "openfda": {"nui": ["N0000191420", "M0018236"], "unii": ["D7NLD2JX7U"], "rxcui": ["1592279"], "spl_set_id": ["ea26490e-fd32-4807-8556-eb6f5f963c23"], "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 in 1 CARTON (69238-1642-7)  / 270 CAPSULE in 1 BOTTLE", "package_ndc": "69238-1642-7", "marketing_start_date": "20220107"}], "brand_name": "Pirfenidone", "product_id": "69238-1642_d7214722-7cee-4a8a-9b9e-8955333a1146", "dosage_form": "CAPSULE", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "69238-1642", "generic_name": "Pirfenidone", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pirfenidone", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "267 mg/1"}], "application_number": "ANDA212569", "marketing_category": "ANDA", "marketing_start_date": "20220107", "listing_expiration_date": "20261231"}