Home NDC 0378-2330 Rufinamide
Product NDC 0378-2330
11-digit product format 003782330
Labeler code 0378
Product ID 0378-2330_9e06d86c-b2bd-4afa-95f8-58622d83fd65
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rufinamide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA205095
Marketing category ANDA
Marketing start 2021-06-01
Marketing end 0000-00-00
Substance RUFINAMIDE
Active strength 200 mg/1
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 A205095-001 RUFINAMIDE RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 A205095-002 RUFINAMIDE RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16
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 3 · 82 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 A205095-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205095-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205095-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205095-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205095-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205095-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205095-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205095-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205095-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205095-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205095-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205095-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205095-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205095-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205095-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205095-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205095-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205095-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205095-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205095-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205095-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205095-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205095-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205095-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205095-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205095-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205095-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205095-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205095-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205095-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205095-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205095-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205095-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205095-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205095-001 RUFINAMIDE 200MG TABLET / ORAL 2016-05-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205095-002 RUFINAMIDE 400MG TABLET / ORAL 2016-05-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205095-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205095-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205095-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A205095-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-2330 RUFINAMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 5 Legacy NDC 20250101_c49c9768-67dc-4ea6-b880-e3cf17f68ec6.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0378-2330-78 00378233078 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2330-78) 2021-06-01 0000-00-00 No No Current