Home NDC 60687-643-21 Rufinamide
Product NDC 60687-643
Requested package NDC 60687-643-21
11-digit product format 606870643
Labeler code 60687
Product ID 60687-643_e0c90c5c-48fe-5369-e053-2a95a90a9d0e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rufinamide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler American Health Packaging
Application ANDA205075
Marketing category ANDA
Marketing start 2022-06-20
Marketing end 0000-00-00
Substance RUFINAMIDE
Active strength 400 mg/1
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A205075-001 RUFINAMIDE RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 A205075-002 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 · 86 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 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205075-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205075-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
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 rufinamide RUFINAMIDE Glenmark Pharmaceuticals Inc., USA da9ee326-a383-4d46-9d4e-fcc2be3d2680 2026-01-23 Warnings, Adverse reactions Exact identifier application applno (ANDA): 205075 application number: ANDA205075
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60687-643-21 60687064321 30 BLISTER PACK in 1 CARTON (60687-643-21) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-643-11) 30 blister pack 2022-06-20 0000-00-00 No No Current