Home NDC 60505-4681-9 Pirfenidone
Product NDC 60505-4681
Requested package NDC 60505-4681-9
11-digit product format 605054681
Labeler code 60505
Product ID 60505-4681_9fc7c490-3a02-c87d-8ecf-a7ad374237bf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pirfenidone
Dosage form TABLET
Route ORAL
Labeler Apotex Corp.
Application ANDA212709
Marketing category ANDA
Marketing start 2024-04-09
Substance PIRFENIDONE
Active strength 267 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 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 A212709-001 PIRFENIDONE PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 A212709-002 PIRFENIDONE PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31
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 · 48 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 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PIRFENIDONE 267 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-4681-7 Pirfenidone 270 in 1 BOTTLE TABLET 270 4 60505-4681-9 Pirfenidone 90 in 1 BOTTLE TABLET 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-4681 PIRFENIDONE (PIRFENIDONE ) TABLET [APOTEX CORP.] 3 Current NDC, 2 package rows 20240522_9ccfe91e-d1fc-d4c1-115b-dd7859b2c3e6.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pirfenidone PIRFENIDONE Golden State Medical Supply, Inc. 1b3261fe-c066-6e86-e063-6294a90a675c 2025-11-24 Warnings, Adverse reactions Exact identifier application applno (ANDA): 212709 application number: ANDA212709
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60505-4681-9 60505468109 90 TABLET in 1 BOTTLE (60505-4681-9) 90 tablet 2024-04-09 No No Current