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 CAPSULE
Routes
ORAL
Active Ingredients

pirfenidone 267 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-2158
Product ID 0781-2158_dec54143-b962-4f6c-a59c-578d93ca1142
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212600
Listing Expiration 2026-12-31
Marketing Start 2023-01-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07812158
Hyphenated Format 0781-2158

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 ANDA212600 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 267 mg/1
source: ndc
Packaging
  • 270 CAPSULE in 1 BOTTLE, PLASTIC (0781-2158-32)
source: ndc

Packages (1)

0781-2158-32 270 CAPSULE in 1 BOTTLE, PLASTIC (0781-2158-32)

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": "dec54143-b962-4f6c-a59c-578d93ca1142", "openfda": {"nui": ["N0000191420", "M0018236"], "unii": ["D7NLD2JX7U"], "rxcui": ["1592279"], "spl_set_id": ["945d4337-7d18-4d84-807b-8ae13750c76d"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "270 CAPSULE in 1 BOTTLE, PLASTIC (0781-2158-32)", "package_ndc": "0781-2158-32", "marketing_start_date": "20230109"}], "brand_name": "Pirfenidone", "product_id": "0781-2158_dec54143-b962-4f6c-a59c-578d93ca1142", "dosage_form": "CAPSULE", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "0781-2158", "generic_name": "Pirfenidone", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pirfenidone", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "267 mg/1"}], "application_number": "ANDA212600", "marketing_category": "ANDA", "marketing_start_date": "20230109", "listing_expiration_date": "20261231"}