Rizatriptan Benzoate

Product NDC
53002-1713
11-digit product format
530021713
Labeler code
53002
Product ID
53002-1713_67f55b41-eb9b-4568-b162-d7e7c1df64ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
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
2021-12-31
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 productproduct53002-1713IInactivated by FDA2026-08-17
excluded packagepackage53002-171353002-1713-1IInactivated 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 · 22 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 packagepackage53002-1713-1IInactivated 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 packagepackage53002-1713-1IInactivated 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 packagepackage53002-1713-1IInactivated 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 packagepackage53002-1713-1IInactivated 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 packagepackage53002-1713-1IInactivated 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 packagepackage53002-1713-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-1713-1UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-1713-1UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-1713-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53002-1713-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53002-1713-1IInactivated by FDA9bebd1f3094a…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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1713-1Rizatriptan Benzoate3 in 1 CARTONTABLET35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1713RIZATRIPTAN BENZOATE TABLET [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 1 package rows20230609_6535f200-ffa3-4564-972c-3bdadcde4a9b.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 TabletPSN6535f200-ffa3-4564-972c-3bdadcde4a9b5
314209rizatriptan 10 MG Oral TabletSCD6535f200-ffa3-4564-972c-3bdadcde4a9b5
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY6535f200-ffa3-4564-972c-3bdadcde4a9b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1713-1530021713013 TABLET in 1 CARTON (53002-1713-1) 3 tablet2018-10-010000-00-00NoNoCurrent