pirfenidone

Generic: pirfenidone

Labeler: alembic pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pirfenidone
Generic Name pirfenidone
Labeler alembic pharmaceuticals inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

pirfenidone 267 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-479
Product ID 62332-479_9f41a23e-cc34-4b25-871d-deeef997fe8d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212708
Listing Expiration 2026-12-31
Marketing Start 2022-06-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62332479
Hyphenated Format 62332-479

Supplemental Identifiers

RxCUI
1868014 1868018
UPC
0362332479719
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 ANDA212708 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 267 mg/1
source: ndc
Packaging
  • 270 TABLET, COATED in 1 BOTTLE (62332-479-27)
  • 3 BOTTLE in 1 CARTON (62332-479-64) / 90 TABLET, COATED in 1 BOTTLE
  • 500 TABLET, COATED in 1 BOTTLE (62332-479-71)
source: ndc

Packages (3)

62332-479-27 270 TABLET, COATED in 1 BOTTLE (62332-479-27) 62332-479-64 3 BOTTLE in 1 CARTON (62332-479-64) / 90 TABLET, COATED in 1 BOTTLE 62332-479-71 500 TABLET, COATED in 1 BOTTLE (62332-479-71)

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": "9f41a23e-cc34-4b25-871d-deeef997fe8d", "openfda": {"nui": ["N0000191420", "M0018236"], "upc": ["0362332479719"], "unii": ["D7NLD2JX7U"], "rxcui": ["1868014", "1868018"], "spl_set_id": ["9214862e-9ef7-4370-856a-f5697978270a"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "270 TABLET, COATED in 1 BOTTLE (62332-479-27)", "package_ndc": "62332-479-27", "marketing_start_date": "20221122"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (62332-479-64)  / 90 TABLET, COATED in 1 BOTTLE", "package_ndc": "62332-479-64", "marketing_start_date": "20220610"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (62332-479-71)", "package_ndc": "62332-479-71", "marketing_start_date": "20220610"}], "brand_name": "Pirfenidone", "product_id": "62332-479_9f41a23e-cc34-4b25-871d-deeef997fe8d", "dosage_form": "TABLET, COATED", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "62332-479", "generic_name": "Pirfenidone", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pirfenidone", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "267 mg/1"}], "application_number": "ANDA212708", "marketing_category": "ANDA", "marketing_start_date": "20220610", "listing_expiration_date": "20261231"}