pirfenidone

Generic: pirfenidone

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pirfenidone
Generic Name pirfenidone
Labeler micro labs limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

pirfenidone 267 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-335
Product ID 42571-335_36ba36c4-7b9d-e62c-e063-6394a90acdab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212680
Listing Expiration 2026-12-31
Marketing Start 2022-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571335
Hyphenated Format 42571-335

Supplemental Identifiers

RxCUI
1868014 1868018
UPC
0342571335908 0342571336905 0342571335397
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 ANDA212680 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 267 mg/1
source: ndc
Packaging
  • 3 TABLET, FILM COATED in 1 CARTON (42571-335-39)
  • 90 BOTTLE in 1 CARTON (42571-335-90) / 90 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

42571-335-39 3 TABLET, FILM COATED in 1 CARTON (42571-335-39) 42571-335-90 90 BOTTLE in 1 CARTON (42571-335-90) / 90 TABLET, FILM COATED in 1 BOTTLE

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": "36ba36c4-7b9d-e62c-e063-6394a90acdab", "openfda": {"nui": ["N0000191420", "M0018236"], "upc": ["0342571335908", "0342571336905", "0342571335397"], "unii": ["D7NLD2JX7U"], "rxcui": ["1868014", "1868018"], "spl_set_id": ["1abc06c7-6a45-4a0b-b2da-c228aaa137ed"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET, FILM COATED in 1 CARTON (42571-335-39)", "package_ndc": "42571-335-39", "marketing_start_date": "20221201"}, {"sample": false, "description": "90 BOTTLE in 1 CARTON (42571-335-90)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "42571-335-90", "marketing_start_date": "20221201"}], "brand_name": "Pirfenidone", "product_id": "42571-335_36ba36c4-7b9d-e62c-e063-6394a90acdab", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "42571-335", "generic_name": "Pirfenidone", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pirfenidone", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "267 mg/1"}], "application_number": "ANDA212680", "marketing_category": "ANDA", "marketing_start_date": "20221201", "listing_expiration_date": "20261231"}