pirfenidone capsule, 267 mg (33342-461)

Drug Facts

Product Profile

Brand Name pirfenidone capsule, 267 mg

Generic Name pirfenidone capsule, 267 mg

Labeler macleods pharmaceuticals limited

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

pirfenidone 267 mg/1

Manufacturer

Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-461

Product ID 33342-461_3e8acd31-bbc7-48d5-956d-6cb04cbdc96c

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212748

Listing Expiration 2026-12-31

Marketing Start 2020-07-20

Pharmacologic Class

Established (EPC)

pyridone [epc]

Chemical Structure

pyridones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342461

Hyphenated Format 33342-461

Supplemental Identifiers

RxCUI

1592279

UPC

0333342461353 0333342461360 0333342461582 0333342461827 0333342461384 0333342461810

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 capsule, 267 mg (source: ndc)

Generic Name pirfenidone capsule, 267 mg (source: ndc)

Application Number ANDA212748 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

267 mg/1

source: ndc

Packaging

1 BLISTER PACK in 1 CARTON (33342-461-38) / 63 CAPSULE in 1 BLISTER PACK
270 CAPSULE in 1 BOTTLE (33342-461-58)
1 BLISTER PACK in 1 CARTON (33342-461-82) / 252 CAPSULE in 1 BLISTER PACK

source: ndc

Packages (3)

33342-461-38 1 BLISTER PACK in 1 CARTON (33342-461-38) / 63 CAPSULE in 1 BLISTER PACK 33342-461-58 270 CAPSULE in 1 BOTTLE (33342-461-58) 33342-461-82 1 BLISTER PACK in 1 CARTON (33342-461-82) / 252 CAPSULE in 1 BLISTER PACK

Ingredients (1)

pirfenidone (267 mg/1)

Linked Drug Pages (1)

Pirfenidone Capsule, 267 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3e8acd31-bbc7-48d5-956d-6cb04cbdc96c", "openfda": {"nui": ["N0000191420", "M0018236"], "upc": ["0333342461353", "0333342461360", "0333342461582", "0333342461827", "0333342461384", "0333342461810"], "unii": ["D7NLD2JX7U"], "rxcui": ["1592279"], "spl_set_id": ["3e8acd31-bbc7-48d5-956d-6cb04cbdc96c"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (33342-461-38)  / 63 CAPSULE in 1 BLISTER PACK", "package_ndc": "33342-461-38", "marketing_start_date": "20200720"}, {"sample": false, "description": "270 CAPSULE in 1 BOTTLE (33342-461-58)", "package_ndc": "33342-461-58", "marketing_start_date": "20200720"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (33342-461-82)  / 252 CAPSULE in 1 BLISTER PACK", "package_ndc": "33342-461-82", "marketing_start_date": "20200720"}], "brand_name": "Pirfenidone Capsule, 267 mg", "product_id": "33342-461_3e8acd31-bbc7-48d5-956d-6cb04cbdc96c", "dosage_form": "CAPSULE", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "33342-461", "generic_name": "Pirfenidone Capsule, 267 mg", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pirfenidone Capsule, 267 mg", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "267 mg/1"}], "application_number": "ANDA212748", "marketing_category": "ANDA", "marketing_start_date": "20200720", "listing_expiration_date": "20261231"}