Banzel

Product NDC: 62856-584
11-digit product format: 628560584
Labeler code: 62856
Product ID: 62856-584_0cc6f13a-0289-45f7-980e-3196d7489d75
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rufinamide
Dosage form: SUSPENSION
Route: ORAL
Labeler: Eisai Inc.
Application: NDA201367
Marketing category: NDA
Marketing start: 2011-03-03
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
N201367-001	BANZEL	RUFINAMIDE	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N201367-001	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	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N201367-001	BANZEL	40MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2011-03-03	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N201367-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201367-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201367-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201367-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201367-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201367-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201367-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201367-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201367-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201367-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201367-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201367-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201367-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201367-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201367-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201367-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201367-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201367-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201367-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201367-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201367-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201367-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201367-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201367-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201367-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201367-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201367-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N201367-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N201367-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N201367-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201367-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201367-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201367-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201367-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201367-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201367-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201367-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N201367-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N201367-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N201367-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201367-001	6740669	2022-11-14	Drug substance, Drug product	2011-04-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201367-001	6740669	2022-11-14	Drug substance, Drug product	2011-04-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201367-001	6740669	2022-11-14	Drug substance, Drug product	2011-04-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201367-001	7750028*PED	2019-04-19	Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201367-001	6740669	2022-11-14	Drug substance, Drug product	2011-04-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201367-001	6740669	2022-11-14	Drug substance, Drug product	2011-04-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201367-001	6740669	2022-11-14	Drug substance, Drug product	2011-04-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201367-001	6740669	2022-11-14	Drug substance, Drug product	2011-04-01	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201367-001	6740669	2022-11-14	Drug substance, Drug product	2011-04-01	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201367-001	6740669	2022-11-14	Drug substance, Drug product	2011-04-01	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201367-001	6740669	2022-11-14	Drug substance, Drug product	2011-04-01	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201367-001	7750028*PED	2019-04-19	Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N201367-001	6740669	2022-11-14	Drug substance, Drug product	2011-04-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201367-001	7750028*PED	2019-04-19	Pediatric extension		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N201367-001	6740669	2022-11-14	Drug substance, Drug product	2011-04-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201367-001	7750028*PED	2019-04-19	Pediatric extension		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N201367-001	6740669	2022-11-14	Drug substance, Drug product	2011-04-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201367-001	6740669	2022-11-14	Drug substance, Drug product	2011-04-01	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201367-001	6740669	2022-11-14	Drug substance, Drug product	2011-04-01	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201367-001	6740669*PED	2023-05-14	Pediatric extension		`3a93d1ddd44b…`

Additional Listing Data#

Finished product: Yes
Brand name base: Banzel
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 · 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0a3fa925-1abd-458a-bd57-4ae780a1ef2d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
131b7904-af2d-e086-e6ed-019008086140	Product name	9	20260127
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62856-584-46	Banzel	460 mL in 1 BOTTLE	SUSPENSION	460		45
62856-584-46	Banzel	1 in 1 CARTON	SUSPENSION	1		45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62856-584-46	ML - Milliliter	62856-584	27f79039-c3c6-4cbc-bfa4-969048e811c5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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
62856-584	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Banzel	RUFINAMIDE	Eisai Inc.	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	2022-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201367 application number: NDA201367 ndc (product): 62856-584

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WFW942PR79	RUFINAMIDE	106308-44-5	RUFINAMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
824299	BANZEL 200 MG Oral Tablet	PSN	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	45
1092360	BANZEL 40 MG in 1 mL Oral Suspension	PSN	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	45
824303	BANZEL 400 MG Oral Tablet	PSN	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	45
824295	rufinamide 200 MG Oral Tablet	PSN	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	45
1092357	rufinamide 40 MG in 1 mL Oral Suspension	PSN	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	45
824301	rufinamide 400 MG Oral Tablet	PSN	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	45
824299	rufinamide 200 MG Oral Tablet [Banzel]	SBD	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	45
1092360	rufinamide 40 MG/ML Oral Suspension [Banzel]	SBD	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	45
824303	rufinamide 400 MG Oral Tablet [Banzel]	SBD	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	45
824295	rufinamide 200 MG Oral Tablet	SCD	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	45
1092357	rufinamide 40 MG/ML Oral Suspension	SCD	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	45
824301	rufinamide 400 MG Oral Tablet	SCD	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	45
824299	Banzel 200 MG Oral Tablet	SY	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	45
1092360	Banzel 40 MG per 1 ML Oral Suspension	SY	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	45
1092360	Banzel 40 MG/ML Oral Suspension	SY	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	45
824303	Banzel 400 MG Oral Tablet	SY	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	45
1092357	rufinamide 40 MG per 1 ML Oral Suspension	SY	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	45
1092357	rufinamide 400 MG per 10 ML Oral Suspension	SY	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	45

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62856-584-46	62856058446	1 BOTTLE in 1 CARTON (62856-584-46) / 460 mL in 1 BOTTLE	1 bottle	2011-03-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Banzel	Eisai Inc. \| Eisai Co., Ltd. \| Ajinomoto Omnichem \| Bushu Pharmaceuticals, Ltd. \| Delpharm Huningue \| Pace Analytical Life Sciences, LLC \| Pharma Packaging Solutions, LLC dba Tjoapack, LLC	2022-12-15	HUMAN PRESCRIPTION DRUG LABEL	45