Home NDC 0054-0426 Rufinamide
Product NDC 0054-0426
11-digit product format 000540426
Labeler code 0054
Product ID 0054-0426_72348f03-413e-4d00-be89-00c719af669b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rufinamide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA204988
Marketing category ANDA
Marketing start 2021-05-30
Substance RUFINAMIDE
Active strength 400 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 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 A204988-001 RUFINAMIDE RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 A204988-002 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 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2021-12-28 21:50 UTC 2021-12 A204988-001 PC 2021-11-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204988-002 PC 2021-11-28 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base Rufinamide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RUFINAMIDE 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WFW942PR79 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 824295 Internal RxNorm lookup 824301 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 0054-0426-13 Rufinamide 30 in 1 BOTTLE TABLET, FILM COATED 30 4 0054-0426-23 Rufinamide 120 in 1 BOTTLE TABLET, FILM COATED 120 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0426 RUFINAMIDE TABLET, FILM COATED [HIKMA PHARMACEUTICALS USA INC.] 4 Current NDC, Legacy NDC, 2 package rows 20221021_56316809-6e73-4717-990b-fc84bf6bf433.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0054-0426-13 00054042613 30 TABLET, FILM COATED in 1 BOTTLE (0054-0426-13) 2021-05-30 0000-00-00 No No Current 0054-0426-23 00054042623 120 TABLET, FILM COATED in 1 BOTTLE (0054-0426-23) 2021-05-30 0000-00-00 No No Current