Rizatriptan Benzoate

Product NDC
45865-825
11-digit product format
458650825
Labeler code
45865
Product ID
45865-825_9ab487ec-5da3-cc72-e053-2a95a90a4e37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA200482
Marketing category
ANDA
Marketing start
2012-12-31
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
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45865-825IInactivated by FDA2026-08-17
excluded packagepackage45865-82545865-825-12IInactivated 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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-825-12IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-825-12IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-825-12IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-825-12IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-825-12IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-825-12IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45865-825-12IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45865-825-12IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45865-825-12IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage45865-825-12IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage45865-825-12IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage45865-825-12IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage45865-825-12IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage45865-825-12IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage45865-825-12IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductEExcluded after deficient or non-compliant submission was not correctedfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage45865-825-12EExcluded after deficient or non-compliant submission was not correctedfb8cb913e6d1…eb8c232b6be0…

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
A200482-001RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2012-12-31
A200482-002RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2012-12-31

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 06:07:402026-07A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2012-12-31caaa826d4ba7…
2026-08-18 06:07:402026-07A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2012-12-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2012-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2012-12-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2012-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2012-12-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2012-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2012-12-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2012-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2012-12-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2012-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2012-12-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2012-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2012-12-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2012-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2012-12-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2012-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2012-12-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2012-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2012-12-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2012-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2012-12-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200482-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200482-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200482-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200482-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200482-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200482-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200482-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200482-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200482-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200482-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200482-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200482-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200482-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200482-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200482-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200482-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200482-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200482-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200482-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200482-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200482-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A200482-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200482-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200482-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A200482-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A200482-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200482-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A200482-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200482-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A200482-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200482-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A200482-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A200482-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A200482-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A200482-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A200482-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200482-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200482-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200482-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A200482-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200482-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A200482-002AB1ea1830bbd6c7…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-825-12Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET62
45865-825-12Rizatriptan Benzoate2 in 1 CARTONTABLET22

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE TABLET [MEDSOURCE PHARMACEUTICALS]1
RIZATRIPTANACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE TABLET [MEDSOURCE PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIZATRIPTAN BENZOATE TABLET [MEDSOURCE PHARMACEUTICALS]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RIZATRIPTAN BENZOATE TABLET [MEDSOURCE PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRIZATRIPTAN BENZOATE TABLET [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIZATRIPTAN BENZOATE TABLET [MEDSOURCE PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRIZATRIPTAN BENZOATE TABLET [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-825RIZATRIPTAN BENZOATE TABLET [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 2 package rows20191228_2086f746-f921-1af1-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN2086f746-f921-1af1-e054-00144ff88e882
314209rizatriptan 10 MG Oral TabletSCD2086f746-f921-1af1-e054-00144ff88e882
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY2086f746-f921-1af1-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-825-12458650825122 BLISTER PACK in 1 CARTON (45865-825-12) > 6 TABLET in 1 BLISTER PACK2 blister pack2015-09-240000-00-00NoNoCurrent