Home NDC 42291-492 Pirfenidone
Product NDC 42291-492
11-digit product format 422910492
Labeler code 42291
Product ID 42291-492_485f7ae5-a12f-d7a7-e063-6294a90a75cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pirfenidone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvKARE
Application ANDA212570
Marketing category ANDA
Marketing start 2023-10-18
Substance PIRFENIDONE
Active strength 801 mg/1
Pharmacologic classes Pyridone [EPC], Pyridones [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212570-001 PIRFENIDONE PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 A212570-002 PIRFENIDONE PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 2 · 60 observed 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 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 5d02ea3f76ae…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212570-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-03-25 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212570-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-03-25 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 60 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Pirfenidone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PIRFENIDONE 801 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1868014 Internal RxNorm lookup 1868018 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 42291-492-09 Pirfenidone 90 in 1 BOTTLE TABLET, FILM COATED 90 2 42291-492-09 Pirfenidone 1 in 1 CARTON TABLET, FILM COATED 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-492 PIRFENIDONE TABLET, FILM COATED [AVKARE] 1 Current NDC, 2 package rows 20231019_08046b49-a8b3-a78d-e063-6394a90a80fa.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 · 3 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 42291-492-09 42291049209 1 BOTTLE in 1 CARTON (42291-492-09) / 90 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2023-10-18 No No Current