Rizatriptan Benzoate

Product NDC
59746-446
11-digit product format
597460446
Labeler code
59746
Product ID
59746-446_728ba46b-87f2-4d61-aa9e-d1d86ffac737
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Jubilant Cadista Pharmaceuticals Inc.
Application
ANDA203334
Marketing category
ANDA
Marketing start
2012-03-01
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 productproduct59746-446DDiscontinued by firm2026-08-03
excluded packagepackage59746-44659746-446-14DDiscontinued by firm2026-08-03

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59746-446-14d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59746-446-14f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59746-446-142ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59746-446-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59746-446-14cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59746-446-14cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59746-446-14302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59746-446-14ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59746-446-140efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59746-446-14ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59746-446-14367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59746-446-14557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage59746-446-148af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage59746-446-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage59746-446-141332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A203334-001RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-16
A203334-002RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-16

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2015-10-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2015-10-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203334-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-16782e0a99824c…
2021-12-28 21:50 UTC2021-12A203334-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2015-10-16782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A203334-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203334-002AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203334-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203334-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203334-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A203334-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203334-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A203334-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203334-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A203334-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203334-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A203334-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A203334-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A203334-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203334-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A203334-002AB1ea99ee380514…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Rizatriptan BenzoateACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
RizatriptanACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Acesulfame PotassiumINACTIVE INGREDIENT23OV73Q5G9RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
CrospovidoneINACTIVE INGREDIENT68401960MKRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
EthylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
HypromellosesINACTIVE INGREDIENT3NXW29V3WORIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
MannitolINACTIVE INGREDIENT3OWL53L36ARIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
PeppermintINACTIVE INGREDIENTV95R5KMY2BRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Sodium Stearyl FumarateINACTIVE INGREDIENT7CV7WJK4UIRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
StrawberryINACTIVE INGREDIENT4J2TY8Y81VRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-446RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]6Legacy NDC20181217_42454df9-ffd1-d8c0-f6fb-05198ad8a432.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-446-14597460446144 CARTON in 1 CARTON (59746-446-14) > 3 TABLET, ORALLY DISINTEGRATING in 1 CARTON (59746-446-13) 4 carton2014-03-010000-00-00NoNoCurrent