Home NDC 50228-442-10 PIRFENIDONE
Product NDC 50228-442
Requested package NDC 50228-442-10
11-digit product format 502280442
Labeler code 50228
Product ID 50228-442_09af4fec-e2cf-2c8d-e063-6294a90af999
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PIRFENIDONE
Dosage form TABLET
Route ORAL
Labeler ScieGen Pharmaceuticals, Inc.
Application ANDA212078
Marketing category ANDA
Marketing start 2022-08-01
Substance PIRFENIDONE
Active strength 267 mg/1
Pharmacologic classes Pyridone [EPC], Pyridones [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 A212078-001 PIRFENIDONE PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 A212078-002 PIRFENIDONE PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01
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 · 54 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 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base PIRFENIDONE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PIRFENIDONE 267 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 50228-442-10 PIRFENIDONE 1000 in 1 BOTTLE TABLET 1000 2 50228-442-30 PIRFENIDONE 30 in 1 BOTTLE TABLET 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50228-442 PIRFENIDONE TABLET [SCIEGEN PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20231109_155b948e-47f5-4741-8e82-2ed65ccfab7d.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50228-442-10 50228044210 1000 TABLET in 1 BOTTLE (50228-442-10) 1000 tablet 2022-08-01 0000-00-00 No No Current