RIZATRIPTAN BENZOATE

Product NDC
61919-656
Requested package NDC
61919-656-12
11-digit product format
619190656
Labeler code
61919
Product ID
61919-656_4d3a8187-effc-938f-e063-6294a90a86b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RIZATRIPTAN BENZOATE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA202490
Marketing category
ANDA
Marketing start
2019-04-22
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
2027-12-31
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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…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
A202490-001RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31
A202490-002RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202490-001AB
A202490-002AB

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 UTC2026-02A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202490-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A202490-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31782e0a99824c…

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 UTC2026-02A202490-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202490-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202490-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202490-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202490-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202490-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202490-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202490-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202490-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202490-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202490-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202490-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202490-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202490-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202490-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202490-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202490-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202490-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202490-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202490-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202490-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202490-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202490-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202490-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202490-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202490-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202490-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202490-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202490-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202490-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202490-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202490-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202490-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202490-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202490-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202490-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202490-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202490-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202490-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202490-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
RIZATRIPTAN BENZOATE
Listing expiration
2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312840Internal RxNorm lookup
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
673d584c-0691-d2fb-e053-2991aa0a7797Available 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-656-122025-01-30C16284748780-12cef2736-59cc-d83d-e063-dadaa90ab31fRIZATRIPTAN BENZOATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-656-12RIZATRIPTAN BENZOATE12 in 1 CARTONTABLET123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-656-12EA - Each61919-65693765af7-514f-47fc-aaf0-1e29e778b77412019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-656RIZATRIPTAN BENZOATE TABLET [DIRECT RX]2Current NDC, Legacy NDC, 1 package rows20190423_673d584c-0691-d2fb-e053-2991aa0a7797.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 · 12 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): 202490
application number: ANDA202490
ndc (package): 61919-656-12
ndc (product): 61919-656
ndc11 (package): 61919065612
RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEdirect rxb3d981bc-3c9e-8a9e-e053-2995a90a8f652026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202490
application number: ANDA202490
Rizatriptan BenzoateRIZATRIPTAN BENZOATEA-S Medication Solutions187204ef-5370-476a-84b1-e3c54b60c6c22025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202490
application number: ANDA202490
Rizatriptan BenzoateRIZATRIPTAN BENZOATEProficient Rx LPe7414f2d-d7cf-41e5-b457-f5850e8bb7a72025-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202490
application number: ANDA202490
Rizatriptan BenzoateRIZATRIPTAN BENZOATEDirect_Rx05150193-cc2f-8b41-e063-6394a90a184c2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202490
application number: ANDA202490
Rizatriptan BenzoateRIZATRIPTAN BENZOATEBryant Ranch Prepack2598cfb1-f875-43a5-aa10-246e026e96952024-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202490
application number: ANDA202490
Rizatriptan BenzoateRIZATRIPTAN BENZOATEBryant Ranch Prepack03b5a887-d689-48a6-bd41-ae1ab4ae49902024-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202490
application number: ANDA202490
Rizatriptan BenzoateRIZATRIPTAN BENZOATEBryant Ranch Prepack01762e5f-db9a-49b3-8da1-60967970a3182024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202490
application number: ANDA202490
Rizatriptan BenzoateRIZATRIPTAN BENZOATEGolden State Medical Supply, Inc.075f47ee-88d1-102b-e063-6394a90acbf82024-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202490
application number: ANDA202490
Rizatriptan BenzoateRIZATRIPTAN BENZOATERising Pharma Holdings, Inc.222f77ff-d3f7-40f9-989c-e5902f44ef1e2024-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202490
application number: ANDA202490
Rizatriptan BenzoateRIZATRIPTAN BENZOATEAurobindo Pharma Limitedfa0f65b8-96b0-49e4-ac47-9a86fb4aa5f12024-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202490
application number: ANDA202490
Rizatriptan BenzoateRIZATRIPTAN BENZOATEProficient Rx LP4a5b43f6-a5ea-4d6f-941f-3c19f242c8962022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202490
application number: ANDA202490

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN673d584c-0691-d2fb-e053-2991aa0a77973
312840rizatriptan benzoate 5 MG Oral TabletPSN673d584c-0691-d2fb-e053-2991aa0a77973
314209rizatriptan 10 MG Oral TabletSCD673d584c-0691-d2fb-e053-2991aa0a77973
312840rizatriptan 5 MG Oral TabletSCD673d584c-0691-d2fb-e053-2991aa0a77973
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY673d584c-0691-d2fb-e053-2991aa0a77973
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSY673d584c-0691-d2fb-e053-2991aa0a77973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-656-126191906561212 TABLET in 1 CARTON (61919-656-12) 12 tablet2019-04-220000-00-00NoNoCurrent