Home NDC 82249-116 Pirfenidone
Product NDC 82249-116
11-digit product format 822490116
Labeler code 82249
Product ID 82249-116_5ee513cc-1a9c-7189-e063-6394a90ab221
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pirfenidone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Civica Script LLC
Application ANDA212674
Marketing category ANDA
Marketing start 2026-11-02
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 44 .
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 A212674-001 PIRFENIDONE PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 A212674-002 PIRFENIDONE PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21
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 · 58 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 2026-10-15 13:18:30 2026-09 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 c2088c7a36db…2026-09-14 22:38:34 2026-08 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212674-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-09-21 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A212674-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-09-21 ea1830bbd6c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 58 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82249-116-90 82249011690 90 TABLET, FILM COATED in 1 BOTTLE (82249-116-90) 2026-11-02 No No Historical