Home NDC 33342-461 Pirfenidone Capsule, 267 mg
Product NDC 33342-461
11-digit product format 333420461
Labeler code 33342
Product ID 33342-461_3e8acd31-bbc7-48d5-956d-6cb04cbdc96c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pirfenidone Capsule, 267 mg
Dosage form CAPSULE
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA212748
Marketing category ANDA
Marketing start 2020-07-20
Substance PIRFENIDONE
Active strength 267 mg/1
Pharmacologic classes Pyridone [EPC], Pyridones [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212748-001 PIRFENIDONE PIRFENIDONE 267MG CAPSULE / ORAL AB 2024-12-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212748-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A212748-001 PIRFENIDONE 267MG CAPSULE / ORAL AB 2024-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212748-001 PIRFENIDONE 267MG CAPSULE / ORAL AB 2024-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212748-001 PIRFENIDONE 267MG CAPSULE / ORAL AB 2024-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212748-001 PIRFENIDONE 267MG CAPSULE / ORAL AB 2024-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212748-001 PIRFENIDONE 267MG CAPSULE / ORAL AB 2024-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212748-001 PIRFENIDONE 267MG CAPSULE / ORAL AB 2024-12-18 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212748-001 PIRFENIDONE 267MG CAPSULE / ORAL AB 2024-12-18 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Pirfenidone Capsule, 267 mg
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PIRFENIDONE 267 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D7NLD2JX7U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1592279 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33342-461-38 Pirfenidone Capsule, 267 mg 63 in 1 BLISTER PACK CAPSULE 63 1 33342-461-38 Pirfenidone Capsule, 267 mg 1 in 1 CARTON CAPSULE 1 1 33342-461-58 Pirfenidone Capsule, 267 mg 270 in 1 BOTTLE CAPSULE 270 1 33342-461-82 Pirfenidone Capsule, 267 mg 1 in 1 CARTON CAPSULE 1 1 33342-461-82 Pirfenidone Capsule, 267 mg 252 in 1 BLISTER PACK CAPSULE 252 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-461 PIRFENIDONE CAPSULE, 267 MG CAPSULE [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 5 package rows 20250406_3e8acd31-bbc7-48d5-956d-6cb04cbdc96c.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 33342-461-38 33342046138 1 BLISTER PACK in 1 CARTON (33342-461-38) / 63 CAPSULE in 1 BLISTER PACK 1 blister pack 2020-07-20 No No Current 33342-461-58 33342046158 270 CAPSULE in 1 BOTTLE (33342-461-58) 270 capsule 2020-07-20 No No Current 33342-461-82 33342046182 1 BLISTER PACK in 1 CARTON (33342-461-82) / 252 CAPSULE in 1 BLISTER PACK 1 blister pack 2020-07-20 No No Current