Home NDC 51407-914 Pirfenidone
Product NDC 51407-914
11-digit product format 514070914
Labeler code 51407
Product ID 51407-914_5c3f075f-0b77-14ec-e063-6394a90afc9f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pirfenidone
Dosage form TABLET
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA212709
Marketing category ANDA
Marketing start 2023-05-31
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 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 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 · 50 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 A212709-001 PIRFENIDONE 267MG TABLET / ORAL AB 2023-05-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A212709-002 PIRFENIDONE 801MG TABLET / ORAL AB 2023-05-31 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 50 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 801 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51407-914-90 Pirfenidone 90 in 1 BOTTLE TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51407-914 PIRFENIDONE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 Current NDC, 1 package rows 20240620_1b3261fe-c066-6e86-e063-6294a90a675c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51407-914-90 51407091490 90 TABLET in 1 BOTTLE (51407-914-90) 90 tablet 2024-04-30 No No Current