pirfenidone

Generic: pirfenidone

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

Drug Facts

Product Profile

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

pirfenidone 801 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-480
Product ID 46708-480_5dd2966d-35b0-4a80-a677-bca6f4c69311
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 46708480
Hyphenated Format 46708-480

Supplemental Identifiers

RxCUI
1868014 1868018
UPC
0346708479718
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
  • 801 mg/1
source: ndc
Packaging
  • 500 TABLET, COATED in 1 BOTTLE (46708-480-71)
  • 90 TABLET, COATED in 1 BOTTLE (46708-480-90)
source: ndc

Packages (2)

46708-480-71 500 TABLET, COATED in 1 BOTTLE (46708-480-71) 46708-480-90 90 TABLET, COATED in 1 BOTTLE (46708-480-90)

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": "5dd2966d-35b0-4a80-a677-bca6f4c69311", "openfda": {"nui": ["N0000191420", "M0018236"], "upc": ["0346708479718"], "unii": ["D7NLD2JX7U"], "rxcui": ["1868014", "1868018"], "spl_set_id": ["6e4f991a-c9e3-4121-97d0-d07954f17336"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (46708-480-71)", "package_ndc": "46708-480-71", "marketing_start_date": "20220610"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (46708-480-90)", "package_ndc": "46708-480-90", "marketing_start_date": "20220610"}], "brand_name": "Pirfenidone", "product_id": "46708-480_5dd2966d-35b0-4a80-a677-bca6f4c69311", "dosage_form": "TABLET, COATED", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "46708-480", "generic_name": "Pirfenidone", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pirfenidone", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "801 mg/1"}], "application_number": "ANDA212708", "marketing_category": "ANDA", "marketing_start_date": "20220610", "listing_expiration_date": "20261231"}