Rizatriptan Benzoate

Product NDC
71335-1577
Requested package NDC
71335-1577-5
11-digit product format
713351577
Labeler code
71335
Product ID
71335-1577_ee127543-b17b-4856-8f68-23c74a3d9aac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203269
Marketing category
ANDA
Marketing start
2012-06-25
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 packagepackage71335-157771335-1577-5DDiscontinued by firm2026-08-10

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 · 12 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…

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
A203269-001RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-18
A203269-002RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203269-001AB
A203269-002AB

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 UTC2026-02A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203269-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2016-02-18782e0a99824c…
2021-12-28 21:50 UTC2021-12A203269-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2016-02-18782e0a99824c…

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 UTC2026-02A203269-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203269-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203269-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203269-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203269-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203269-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203269-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203269-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203269-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203269-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203269-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203269-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203269-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203269-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203269-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203269-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203269-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203269-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203269-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203269-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203269-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203269-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203269-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203269-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203269-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203269-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203269-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203269-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203269-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203269-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203269-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203269-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203269-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203269-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203269-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203269-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203269-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203269-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203269-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203269-002AB1782e0a99824c…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rizatriptan BenzoateRIZATRIPTAN BENZOATEBryant Ranch Prepack6391d2a1-252e-4e50-9d80-4dce12eabc8f2025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203269
application number: ANDA203269
RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEDirect Rxd60560d5-8e52-099d-e053-2a95a90a20af2025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203269
application number: ANDA203269
Rizatriptan BenzoateRIZATRIPTAN BENZOATEBryant Ranch Prepack65ae33a2-975f-4a4e-a1a5-42fe451a24342023-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203269
application number: ANDA203269
Rizatriptan BenzoateRIZATRIPTAN BENZOATEA-S Medication Solutions5001b8cc-8e52-4a00-a830-3b2f79766a032023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203269
application number: ANDA203269
Rizatriptan BenzoateRIZATRIPTAN BENZOATEAscend Laboratories, LLC07e66554-bc85-4853-9f40-1249617630a92022-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203269
application number: ANDA203269

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1577-57133515770530 TABLET in 1 BOTTLE (71335-1577-5) 30 tablet2022-02-140000-00-00NoNoCurrent