pirfenidone

Generic: pirfenidone

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

Drug Facts

Product Profile

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

pirfenidone 801 mg/1

Manufacturer
EXELAN PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 76282-716
Product ID 76282-716_3449172d-fe07-4924-ad05-89b854600aeb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212078
Listing Expiration 2026-12-31
Marketing Start 2022-08-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282716
Hyphenated Format 76282-716

Supplemental Identifiers

RxCUI
1868014 1868018
UPC
0376282717272 0376282716909 0376282716275 0376282717906
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 ANDA212078 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 801 mg/1
source: ndc
Packaging
  • 270 TABLET, COATED in 1 BOTTLE (76282-716-27)
  • 90 TABLET, COATED in 1 BOTTLE (76282-716-90)
source: ndc

Packages (2)

76282-716-27 270 TABLET, COATED in 1 BOTTLE (76282-716-27) 76282-716-90 90 TABLET, COATED in 1 BOTTLE (76282-716-90)

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": "3449172d-fe07-4924-ad05-89b854600aeb", "openfda": {"nui": ["N0000191420", "M0018236"], "upc": ["0376282717272", "0376282716909", "0376282716275", "0376282717906"], "unii": ["D7NLD2JX7U"], "rxcui": ["1868014", "1868018"], "spl_set_id": ["c171e4af-1619-4712-958f-ef96adfede37"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["EXELAN PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "270 TABLET, COATED in 1 BOTTLE (76282-716-27)", "package_ndc": "76282-716-27", "marketing_start_date": "20220802"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (76282-716-90)", "package_ndc": "76282-716-90", "marketing_start_date": "20220802"}], "brand_name": "Pirfenidone", "product_id": "76282-716_3449172d-fe07-4924-ad05-89b854600aeb", "dosage_form": "TABLET, COATED", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "76282-716", "generic_name": "Pirfenidone", "labeler_name": "EXELAN PHARMACEUTICALS INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pirfenidone", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "801 mg/1"}], "application_number": "ANDA212078", "marketing_category": "ANDA", "marketing_start_date": "20220802", "listing_expiration_date": "20261231"}