Home NDC 0904-7398 PIRFENIDONE
Product NDC 0904-7398
11-digit product format 009047398
Labeler code 0904
Product ID 0904-7398_24b60d05-c1f7-4fba-ba4f-009eceb0c409
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PIRFENIDONE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler MAJOR PHARMACEUTICALS
Application ANDA212772
Marketing category ANDA
Marketing start 2022-05-24
Marketing end 2028-01-31
Substance PIRFENIDONE
Active strength 801 mg/1
Pharmacologic classes Pyridone [EPC], Pyridones [CS]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A212772-001 PIRFENIDONE PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 A212772-002 PIRFENIDONE PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24
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 · 62 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 2026-09-14 22:38:34 2026-08 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212772-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-05-24 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A212772-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-05-24 ea1830bbd6c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 62 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base PIRFENIDONE Active Ingredients# Ingredient, Strength table Ingredient Strength PIRFENIDONE 801 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-7398-89 PIRFENIDONE 90 in 1 BOTTLE TABLET, FILM COATED 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7398 PIRFENIDONE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 Current NDC, 1 package rows 20240303_73db516f-8c80-431f-8190-33081718cf8d.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0904-7398-89 00904739889 90 TABLET, FILM COATED in 1 BOTTLE (0904-7398-89) 2024-03-02 2028-01-31 No No Historical