Rizatriptan Benzoate

Product NDC
63629-7433
Requested package NDC
63629-7433-2
11-digit product format
636297433
Labeler code
63629
Product ID
63629-7433_440c4581-1f01-4ae7-b627-cb236ef59516
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204339
Marketing category
ANDA
Marketing start
2016-07-22
Marketing end
0000-00-00
Substance
RIZATRIPTAN BENZOATE
Active strength
10 mg/1
Pharmacologic classes
Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-743363629-7433-2IInactivated by FDA2026-08-17

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 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204339-001RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2013-07-01
A204339-002RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2013-07-01

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2013-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2013-07-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2013-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2013-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2013-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2013-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2013-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2013-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2013-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2013-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2013-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2013-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2013-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2013-07-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2013-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2013-07-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2013-07-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2013-07-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2013-07-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2013-07-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2013-07-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2013-07-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2013-07-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2013-07-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2013-07-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2013-07-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2013-07-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2013-07-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2013-07-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2013-07-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-07-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-07-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-07-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-07-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-07-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-07-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-07-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-07-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204339-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-07-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204339-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-07-01bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204339-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204339-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204339-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204339-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204339-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204339-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204339-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204339-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204339-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204339-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204339-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A204339-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204339-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204339-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A204339-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A204339-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204339-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A204339-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204339-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A204339-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204339-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A204339-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A204339-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A204339-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204339-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A204339-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204339-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204339-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204339-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A204339-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204339-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A204339-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204339-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204339-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204339-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204339-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204339-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204339-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204339-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204339-002AB13f0d92c62455…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2791553-0b76-42f4-8d49-af3eda072bfbProduct name120251117
707ffe6e-db52-42b0-9a65-a0c00213f04fProduct name120231006
8b537454-32b8-7e64-1395-258682782d07Product name520170424

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-7433-12024-01-30These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets. Rizatriptan Benzoate Tablets, for oral use Initial U.S. Approval: 1998
63629-7433-22024-01-30These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets. Rizatriptan Benzoate Tablets, for oral use Initial U.S. Approval: 1998
63629-7433-32024-01-30These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets. Rizatriptan Benzoate Tablets, for oral use Initial U.S. Approval: 1998
63629-7433-42024-01-30These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets. Rizatriptan Benzoate Tablets, for oral use Initial U.S. Approval: 1998
63629-7433-52024-01-30These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets. Rizatriptan Benzoate Tablets, for oral use Initial U.S. Approval: 1998
63629-7433-62024-01-30These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets. Rizatriptan Benzoate Tablets, for oral use Initial U.S. Approval: 1998
63629-7433-72024-01-30These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets. Rizatriptan Benzoate Tablets, for oral use Initial U.S. Approval: 1998
63629-7433-12020-10-28These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets. Rizatriptan Benzoate Tablets, for oral use Initial U.S. Approval: 1998
63629-7433-22020-10-28These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets. Rizatriptan Benzoate Tablets, for oral use Initial U.S. Approval: 1998
63629-7433-32020-10-28These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets. Rizatriptan Benzoate Tablets, for oral use Initial U.S. Approval: 1998
63629-7433-42020-10-28These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets. Rizatriptan Benzoate Tablets, for oral use Initial U.S. Approval: 1998
63629-7433-52020-10-28These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets. Rizatriptan Benzoate Tablets, for oral use Initial U.S. Approval: 1998
63629-7433-12020-01-31These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets. Rizatriptan Benzoate Tablets, for oral use Initial U.S. Approval: 1998
63629-7433-22020-01-31These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets. Rizatriptan Benzoate Tablets, for oral use Initial U.S. Approval: 1998
63629-7433-32020-01-31These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets. Rizatriptan Benzoate Tablets, for oral use Initial U.S. Approval: 1998
63629-7433-42020-01-31These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets. Rizatriptan Benzoate Tablets, for oral use Initial U.S. Approval: 1998
63629-7433-52020-01-31These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets. Rizatriptan Benzoate Tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7433-1Rizatriptan Benzoate10 in 1 BOTTLETABLET107
63629-7433-2Rizatriptan Benzoate6 in 1 BOTTLETABLET67
63629-7433-3Rizatriptan Benzoate90 in 1 BOTTLETABLET907
63629-7433-4Rizatriptan Benzoate9 in 1 BOTTLETABLET97
63629-7433-5Rizatriptan Benzoate30 in 1 BOTTLETABLET307
63629-7433-6Rizatriptan Benzoate18 in 1 BOTTLETABLET187
63629-7433-7Rizatriptan Benzoate12 in 1 BOTTLETABLET127

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7433RIZATRIPTAN BENZOATE TABLET [BRYANT RANCH PREPACK]7Legacy NDC, 7 package rows20220115_32094145-be64-4f14-ace7-b29c9b051daf.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEDIRECT RX673d584c-0691-d2fb-e053-2991aa0a77972026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204339
application number: ANDA204339
Rizatriptan BenzoateRIZATRIPTAN BENZOATECipla USA Inc.f462a507-921c-41c2-93ba-36003b6e89142022-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204339
application number: ANDA204339

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN32094145-be64-4f14-ace7-b29c9b051daf7
314209rizatriptan 10 MG Oral TabletSCD32094145-be64-4f14-ace7-b29c9b051daf7
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY32094145-be64-4f14-ace7-b29c9b051daf7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7433-2636297433026 TABLET in 1 BOTTLE (63629-7433-2) 6 tablet2021-12-220000-00-00NoNoCurrent