Rizatriptan Benzoate

Product NDC
50090-3343
11-digit product format
500903343
Labeler code
50090
Product ID
50090-3343_90fa90cf-19f1-412f-b950-c360dae8c3e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203269
Marketing category
ANDA
Marketing start
2012-06-25
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
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Rizatriptan Benzoate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIZATRIPTAN BENZOATE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WR978S7QHHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
314209Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5001b8cc-8e52-4a00-a830-3b2f79766a03Available on FDA.report

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
50090-3343-0Rizatriptan Benzoate3 in 1 CARTONTABLET37
50090-3343-0Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET67

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3343-0EA - Each50090-33439b13d11e-c427-41d1-8e44-bba22d138a9212019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3343RIZATRIPTAN BENZOATE TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20230208_5001b8cc-8e52-4a00-a830-3b2f79766a03.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 · 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
ndc (product): 50090-3343
Rizatriptan BenzoateRIZATRIPTAN BENZOATEAscend Laboratories, LLC07e66554-bc85-4853-9f40-1249617630a92022-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203269
application number: ANDA203269

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN5001b8cc-8e52-4a00-a830-3b2f79766a037
314209rizatriptan 10 MG Oral TabletSCD5001b8cc-8e52-4a00-a830-3b2f79766a037
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY5001b8cc-8e52-4a00-a830-3b2f79766a037

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3343-0500903343003 BLISTER PACK in 1 CARTON (50090-3343-0) / 6 TABLET in 1 BLISTER PACK3 blister pack2018-01-220000-00-00NoNoCurrent