Rizatriptan Benzoate ODT

Product NDC
72189-341
11-digit product format
721890341
Labeler code
72189
Product ID
72189-341_2c4c5f32-a754-7f96-e063-6394a90ad938
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate ODT
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Direct Rx
Application
ANDA203062
Marketing category
ANDA
Marketing start
2022-03-28
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

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-341-09ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-341-090efc9e666f02…f202fb6c5f17…

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
A203062-001RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01
A203062-002RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203062-001AB
A203062-002AB

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 UTC2026-02A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203062-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01782e0a99824c…
2021-12-28 21:50 UTC2021-12A203062-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01782e0a99824c…

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 UTC2026-02A203062-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203062-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203062-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203062-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203062-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203062-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203062-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203062-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203062-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203062-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203062-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203062-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203062-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203062-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203062-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203062-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203062-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203062-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203062-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203062-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203062-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203062-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203062-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203062-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203062-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203062-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203062-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203062-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203062-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203062-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203062-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203062-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203062-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203062-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203062-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203062-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203062-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203062-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203062-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203062-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Rizatriptan Benzoate ODT
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
312837Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
db489d19-1509-c979-e053-2a95a90a4410Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-341-09Rizatriptan Benzoate ODT9 in 1 BOTTLETABLET, ORALLY DISINTEGRATING92

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-341-09EA - Each72189-3415ebe3040-1ffd-4d33-b759-1ce69607e4e812022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-341RIZATRIPTAN BENZOATE ODT TABLET, ORALLY DISINTEGRATING [DIRECT RX]2Current NDC, Legacy NDC, 1 package rows20250123_db489d19-1509-c979-e053-2a95a90a4410.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rizatriptan BenzoateRIZATRIPTAN BENZOATEBryant Ranch Prepack11a7f243-3a8b-41fd-a9fa-1dd2dcafab932026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203062
application number: ANDA203062
Rizatriptan BenzoateRIZATRIPTAN BENZOATEAdvanced Rx of Tennessee, LLC4137a02e-dcec-c14c-e063-6294a90aa44f2025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203062
application number: ANDA203062
Rizatriptan BenzoateRIZATRIPTAN BENZOATEGolden State Medical Supply, Inc.07605de4-bef2-70e8-e063-6394a90a33cc2025-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203062
application number: ANDA203062
Rizatriptan BenzoateRIZATRIPTAN BENZOATEAurobindo Pharma Limiteda8e37688-426c-4290-933d-54a34ae860002025-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203062
application number: ANDA203062
Rizatriptan BenzoateRIZATRIPTAN BENZOATEREMEDYREPACK INC.1e547fac-a9e5-4c7b-adba-4e6b751411832025-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203062
application number: ANDA203062
Rizatriptan BenzoateRIZATRIPTAN BENZOATEAsclemed USA, Inc.8fa794f4-4253-485d-b4ee-9861780313392025-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203062
application number: ANDA203062
Rizatriptan Benzoate ODTRIZATRIPTAN BENZOATE ODTDirect Rxdb489d19-1509-c979-e053-2a95a90a44102025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203062
application number: ANDA203062
ndc (product): 72189-341
Rizatriptan BenzoateRIZATRIPTAN BENZOATEBryant Ranch Prepack74971372-75c6-4682-adbf-1c8e7b748fc12024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203062
application number: ANDA203062
Rizatriptan BenzoateRIZATRIPTAN BENZOATERising Pharma Holdings, Inc.2337e102-8df0-4e7f-81d8-5cb86cd486742024-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203062
application number: ANDA203062
Rizatriptan BenzoateRIZATRIPTAN BENZOATENuCare Pharmaceuticals,Inc.106dd370-c09c-556a-e063-6394a90acfed2024-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203062
application number: ANDA203062
Rizatriptan BenzoateRIZATRIPTAN BENZOATEProficient Rx LP80c124ab-a083-4184-ba6b-199a7681b5d12023-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203062
application number: ANDA203062

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSNdb489d19-1509-c979-e053-2a95a90a44102
312837rizatriptan 10 MG Disintegrating Oral TabletSCDdb489d19-1509-c979-e053-2a95a90a44102
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSYdb489d19-1509-c979-e053-2a95a90a44102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-341-09721890341099 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (72189-341-09) 2022-03-280000-00-00NoNoCurrent