Banzel

Product NDC
75929-098
11-digit product format
759290098
Labeler code
75929
Product ID
75929-098_3a98e81d-be3a-16f7-e063-6394a90a6207
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rufinamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pharma Packaging Solutions, LLC dba Tjoapack LLC
Application
NDA021911
Marketing category
NDA
Marketing start
2008-11-14
Substance
RUFINAMIDE
Active strength
400 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct75929-098DDiscontinued by firm2026-08-07
excluded packagepackage75929-09875929-098-12DDiscontinued by firm2026-08-07
excluded packagepackage75929-09875929-098-51DDiscontinued by firm2026-08-07

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021911-001BANZELRUFINAMIDE100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-11-14
N021911-002BANZELRUFINAMIDE200MGTABLET / ORALABRLD2008-11-14
N021911-003BANZELRUFINAMIDE400MGTABLET / ORALABRLD, RS2008-11-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N021911-002AB
N021911-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021911-001BANZEL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021911-002BANZEL200MGTABLET / ORALABRLD2008-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021911-003BANZEL400MGTABLET / ORALABRLD, RS2008-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021911-001BANZEL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021911-002BANZEL200MGTABLET / ORALABRLD2008-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021911-003BANZEL400MGTABLET / ORALABRLD, RS2008-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021911-001BANZEL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021911-002BANZEL200MGTABLET / ORALABRLD2008-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021911-003BANZEL400MGTABLET / ORALABRLD, RS2008-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021911-001BANZEL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021911-002BANZEL200MGTABLET / ORALABRLD2008-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021911-003BANZEL400MGTABLET / ORALABRLD, RS2008-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021911-001BANZEL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021911-002BANZEL200MGTABLET / ORALABRLD2008-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021911-003BANZEL400MGTABLET / ORALABRLD, RS2008-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021911-001BANZEL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021911-002BANZEL200MGTABLET / ORALABRLD2008-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021911-003BANZEL400MGTABLET / ORALABRLD, RS2008-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021911-001BANZEL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021911-002BANZEL200MGTABLET / ORALABRLD2008-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021911-003BANZEL400MGTABLET / ORALABRLD, RS2008-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021911-001BANZEL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021911-002BANZEL200MGTABLET / ORALABRLD2008-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021911-003BANZEL400MGTABLET / ORALABRLD, RS2008-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021911-001BANZEL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-11-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021911-002BANZEL200MGTABLET / ORALABRLD2008-11-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021911-003BANZEL400MGTABLET / ORALABRLD, RS2008-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021911-001BANZEL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-11-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N021911-002BANZEL200MGTABLET / ORALABRLD2008-11-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N021911-003BANZEL400MGTABLET / ORALABRLD, RS2008-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021911-001BANZEL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-11-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021911-002BANZEL200MGTABLET / ORALABRLD2008-11-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021911-003BANZEL400MGTABLET / ORALABRLD, RS2008-11-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021911-001BANZEL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-11-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021911-002BANZEL200MGTABLET / ORALABRLD2008-11-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021911-003BANZEL400MGTABLET / ORALABRLD, RS2008-11-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021911-001BANZEL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-11-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021911-002BANZEL200MGTABLET / ORALABRLD2008-11-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021911-003BANZEL400MGTABLET / ORALABRLD, RS2008-11-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021911-001BANZEL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-11-148072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021911-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021911-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021911-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021911-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021911-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021911-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021911-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021911-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021911-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021911-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021911-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021911-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021911-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021911-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021911-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021911-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021911-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021911-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021911-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021911-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021911-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021911-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021911-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021911-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021911-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021911-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021911-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021911-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021911-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021911-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021911-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021911-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021911-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021911-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021911-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021911-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021911-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021911-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021911-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021911-003AB1782e0a99824c…

Observed Orange Book patent history#

Patent history page 1 of 4 · 138 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021911-00167406692022-11-14Drug substance, Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021911-0016740669*PED2023-05-14Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021911-00267406692022-11-14Drug substance, Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021911-0026740669*PED2023-05-14Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021911-00367406692022-11-14Drug substance, Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021911-0036740669*PED2023-05-14Pediatric extension5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021911-00167406692022-11-14Drug substance, Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021911-0016740669*PED2023-05-14Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021911-00267406692022-11-14Drug substance, Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021911-0026740669*PED2023-05-14Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021911-00367406692022-11-14Drug substance, Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021911-0036740669*PED2023-05-14Pediatric extension5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021911-00167406692022-11-14Drug substance, Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021911-0016740669*PED2023-05-14Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021911-00267406692022-11-14Drug substance, Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021911-0026740669*PED2023-05-14Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021911-00367406692022-11-14Drug substance, Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021911-0036740669*PED2023-05-14Pediatric extension4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021911-0017750028*PED2019-04-19Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021911-00167406692022-11-14Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021911-0016740669*PED2023-05-14Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021911-0027750028*PED2019-04-19Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021911-00267406692022-11-14Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021911-0026740669*PED2023-05-14Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021911-0037750028*PED2019-04-19Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021911-00367406692022-11-14Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021911-0036740669*PED2023-05-14Pediatric extension74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021911-00167406692022-11-14Drug substance, Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021911-0016740669*PED2023-05-14Pediatric extensionbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021911-00267406692022-11-14Drug substance, Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021911-0026740669*PED2023-05-14Pediatric extensionbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021911-00367406692022-11-14Drug substance, Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021911-0036740669*PED2023-05-14Pediatric extensionbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021911-00167406692022-11-14Drug substance, Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021911-0016740669*PED2023-05-14Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N021911-00267406692022-11-14Drug substance, Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021911-0026740669*PED2023-05-14Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N021911-00367406692022-11-14Drug substance, Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021911-0036740669*PED2023-05-14Pediatric extension782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021911-00167406692022-11-14Drug substance, Drug product87673890dc5c…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BanzelRUFINAMIDEEisai Inc.0a3fa925-1abd-458a-bd57-4ae780a1ef2d2022-12-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 021911
application number: NDA021911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
75929-098-1275929009812120 TABLET, FILM COATED in 1 BOTTLE (75929-098-12) 2008-11-14NoNoHistorical
75929-098-5175929009851120 TABLET, FILM COATED in 1 BOTTLE (75929-098-51) 2008-11-14NoNoHistorical