Home NDC 0054-0528 Rufinamide
Product NDC 0054-0528
11-digit product format 000540528
Labeler code 0054
Product ID 0054-0528_eb1cdda2-10c1-4acc-ab6a-c6aba2c7db80
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rufinamide
Dosage form SUSPENSION
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA207363
Marketing category ANDA
Marketing start 2020-11-01
Substance RUFINAMIDE
Active strength 40 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207363-001 RUFINAMIDE RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207363-001 AB
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 · 41 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 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207363-001 RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB 2019-04-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Rufinamide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RUFINAMIDE 40 mg/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1092357 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 0054-0528-63 Rufinamide 1 in 1 CARTON SUSPENSION 1 5 0054-0528-63 Rufinamide 460 mL in 1 BOTTLE SUSPENSION 460 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0528 RUFINAMIDE SUSPENSION [HIKMA PHARMACEUTICALS USA INC.] 5 Current NDC, Legacy NDC, 2 package rows 20220512_8ef75997-06f6-441f-8320-a23bc13ca2d9.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 · 2 matching rows.
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 0054-0528-63 00054052863 1 BOTTLE in 1 CARTON (0054-0528-63) / 460 mL in 1 BOTTLE 1 bottle 2020-11-01 0000-00-00 No No Current