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 CAPSULE
Routes
ORAL
Active Ingredients

pirfenidone 267 mg/1

Manufacturer
EXELAN PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 76282-715
Product ID 76282-715_2696c9c1-fdbb-4135-862e-ab4cd18ad2aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212077
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 76282715
Hyphenated Format 76282-715

Supplemental Identifiers

RxCUI
1592279
UPC
0376282715902 0376282715278
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 ANDA212077 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 267 mg/1
source: ndc
Packaging
  • 270 CAPSULE in 1 BOTTLE (76282-715-27)
  • 90 CAPSULE in 1 BOTTLE (76282-715-90)
source: ndc

Packages (2)

76282-715-27 270 CAPSULE in 1 BOTTLE (76282-715-27) 76282-715-90 90 CAPSULE in 1 BOTTLE (76282-715-90)

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": "2696c9c1-fdbb-4135-862e-ab4cd18ad2aa", "openfda": {"nui": ["N0000191420", "M0018236"], "upc": ["0376282715902", "0376282715278"], "unii": ["D7NLD2JX7U"], "rxcui": ["1592279"], "spl_set_id": ["1709582c-9975-4dc1-8181-2501ee670eef"], "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 CAPSULE in 1 BOTTLE (76282-715-27)", "package_ndc": "76282-715-27", "marketing_start_date": "20220802"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76282-715-90)", "package_ndc": "76282-715-90", "marketing_start_date": "20220802"}], "brand_name": "PIRFENIDONE", "product_id": "76282-715_2696c9c1-fdbb-4135-862e-ab4cd18ad2aa", "dosage_form": "CAPSULE", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "76282-715", "generic_name": "PIRFENIDONE", "labeler_name": "EXELAN PHARMACEUTICALS INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PIRFENIDONE", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "267 mg/1"}], "application_number": "ANDA212077", "marketing_category": "ANDA", "marketing_start_date": "20220802", "listing_expiration_date": "20261231"}