pirfenidone

Generic: pirfenidone

Labeler: golden state medical supply, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pirfenidone
Generic Name pirfenidone
Labeler golden state medical supply, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pirfenidone 801 mg/1

Manufacturer
Golden State Medical Supply, Inc.

Identifiers & Regulatory

Product NDC 51407-914
Product ID 51407-914_445b8f7f-9ec4-5f1d-e063-6394a90a098b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212709
Listing Expiration 2026-12-31
Marketing Start 2023-05-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51407914
Hyphenated Format 51407-914

Supplemental Identifiers

RxCUI
1868014 1868018
UNII
D7NLD2JX7U
NUI
N0000191420 M0018236

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 ANDA212709 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 801 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (51407-914-90)
source: ndc

Packages (1)

51407-914-90 90 TABLET in 1 BOTTLE (51407-914-90)

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": "445b8f7f-9ec4-5f1d-e063-6394a90a098b", "openfda": {"nui": ["N0000191420", "M0018236"], "unii": ["D7NLD2JX7U"], "rxcui": ["1868014", "1868018"], "spl_set_id": ["1b3261fe-c066-6e86-e063-6294a90a675c"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["Golden State Medical Supply, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (51407-914-90)", "package_ndc": "51407-914-90", "marketing_start_date": "20240430"}], "brand_name": "Pirfenidone", "product_id": "51407-914_445b8f7f-9ec4-5f1d-e063-6394a90a098b", "dosage_form": "TABLET", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "51407-914", "generic_name": "Pirfenidone", "labeler_name": "Golden State Medical Supply, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pirfenidone", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "801 mg/1"}], "application_number": "ANDA212709", "marketing_category": "ANDA", "marketing_start_date": "20230531", "listing_expiration_date": "20261231"}