Home NDC 62856-582 Banzel
Product NDC 62856-582
11-digit product format 628560582
Labeler code 62856
Product ID 62856-582_0cc6f13a-0289-45f7-980e-3196d7489d75
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rufinamide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Eisai Inc.
Application NDA021911
Marketing category NDA
Marketing start 2008-11-14
Substance RUFINAMIDE
Active strength 200 mg/1
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021911-001 BANZEL RUFINAMIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 N021911-002 BANZEL RUFINAMIDE 200MG TABLET / ORAL AB RLD 2008-11-14 N021911-003 BANZEL RUFINAMIDE 400MG TABLET / ORAL AB RLD, RS 2008-11-14
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 4 · 123 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UTC 2026-02 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book patent history# Patent history page 1 of 4 · 138 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021911-001 6740669 2022-11-14 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021911-001 6740669*PED 2023-05-14 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021911-002 6740669 2022-11-14 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021911-002 6740669*PED 2023-05-14 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021911-003 6740669 2022-11-14 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021911-003 6740669*PED 2023-05-14 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021911-001 6740669 2022-11-14 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021911-001 6740669*PED 2023-05-14 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021911-002 6740669 2022-11-14 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021911-002 6740669*PED 2023-05-14 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021911-003 6740669 2022-11-14 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021911-003 6740669*PED 2023-05-14 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021911-001 6740669 2022-11-14 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021911-001 6740669*PED 2023-05-14 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021911-002 6740669 2022-11-14 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021911-002 6740669*PED 2023-05-14 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021911-003 6740669 2022-11-14 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021911-003 6740669*PED 2023-05-14 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021911-001 7750028*PED 2019-04-19 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021911-001 6740669 2022-11-14 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021911-001 6740669*PED 2023-05-14 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021911-002 7750028*PED 2019-04-19 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021911-002 6740669 2022-11-14 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021911-002 6740669*PED 2023-05-14 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021911-003 7750028*PED 2019-04-19 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021911-003 6740669 2022-11-14 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021911-003 6740669*PED 2023-05-14 Pediatric extension 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021911-001 6740669 2022-11-14 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021911-001 6740669*PED 2023-05-14 Pediatric extension bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021911-002 6740669 2022-11-14 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021911-002 6740669*PED 2023-05-14 Pediatric extension bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021911-003 6740669 2022-11-14 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021911-003 6740669*PED 2023-05-14 Pediatric extension bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021911-001 6740669 2022-11-14 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021911-001 6740669*PED 2023-05-14 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021911-002 6740669 2022-11-14 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021911-002 6740669*PED 2023-05-14 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021911-003 6740669 2022-11-14 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021911-003 6740669*PED 2023-05-14 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021911-001 6740669 2022-11-14 Drug substance, Drug product 87673890dc5c…
Additional Listing Data#
Finished product Yes
Brand name base Banzel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RUFINAMIDE 200 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 824295 Internal RxNorm lookup 824299 Internal RxNorm lookup 824301 Internal RxNorm lookup 824303 Internal RxNorm lookup 1092357 Internal RxNorm lookup 1092360 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 62856-582-04 Banzel 4 in 1 BOTTLE TABLET, FILM COATED 4 45 62856-582-52 Banzel 120 in 1 BOTTLE TABLET, FILM COATED 120 45
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RUFINAMIDE ACTIVE INGREDIENT WFW942PR79 BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 RUFINAMIDE ACTIVE MOIETY WFW942PR79 BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM INACTIVE INGREDIENT K679OBS311 BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) INACTIVE INGREDIENT S38J6RZN16 BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 ORANGE INACTIVE INGREDIENT 5EVU04N5QU BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 SORBITOL INACTIVE INGREDIENT 506T60A25R BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 TALC INACTIVE INGREDIENT 7SEV7J4R1U BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 24
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62856-582 BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] 45 Current NDC, Legacy NDC, 2 package rows 20241116_0a3fa925-1abd-458a-bd57-4ae780a1ef2d.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 62856-582-04 62856058204 4 TABLET, FILM COATED in 1 BOTTLE (62856-582-04) 2018-08-08 0000-00-00 Yes No Current 62856-582-52 62856058252 120 TABLET, FILM COATED in 1 BOTTLE (62856-582-52) 2008-11-14 0000-00-00 No No Current