Rizatriptan Benzoate

Product NDC
0093-7472
11-digit product format
000937472
Labeler code
0093
Product ID
0093-7472_fe55c129-f82a-46c6-add0-e9f1d405eec6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA077263
Marketing category
ANDA
Marketing start
2013-02-12
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
A077263-001RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31
A077263-002RIZATRIPTAN 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
A077263-001AB
A077263-002AB

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 UTC2026-02A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077263-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077263-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077263-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077263-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077263-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077263-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077263-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077263-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077263-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A077263-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077263-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077263-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077263-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077263-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077263-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077263-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077263-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077263-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077263-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077263-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A077263-002RIZATRIPTAN 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 UTC2026-02A077263-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077263-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077263-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077263-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077263-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077263-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077263-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077263-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077263-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077263-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077263-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077263-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077263-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077263-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077263-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077263-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077263-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077263-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077263-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077263-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077263-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077263-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077263-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077263-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077263-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077263-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077263-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077263-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077263-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077263-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077263-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077263-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077263-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077263-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077263-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077263-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077263-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077263-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077263-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077263-002AB1782e0a99824c…

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 · 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
4ef60c83-ba48-4134-968b-13800ea9b7f2Available 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
0093-7472-19Rizatriptan Benzoate1 in 1 BLISTER PACKTABLET18
0093-7472-43Rizatriptan Benzoate18 in 1 BOXTABLET188

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7472-19EA - Each0093-74725402122f-c96e-4e53-addf-053fd5a517c612013-03-03
0093-7472-43EA - Each0093-747220cb0d70-de40-4fea-b74c-0a16cc67857812013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE TABLET [TEVA PHARMACEUTICALS USA INC]2
RIZATRIPTANACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE TABLET [TEVA PHARMACEUTICALS USA INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIZATRIPTAN BENZOATE TABLET [TEVA PHARMACEUTICALS USA INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRIZATRIPTAN BENZOATE TABLET [TEVA PHARMACEUTICALS USA INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIZATRIPTAN BENZOATE TABLET [TEVA PHARMACEUTICALS USA INC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2RIZATRIPTAN BENZOATE TABLET [TEVA PHARMACEUTICALS USA INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRIZATRIPTAN BENZOATE TABLET [TEVA PHARMACEUTICALS USA INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7472RIZATRIPTAN BENZOATE TABLET [TEVA PHARMACEUTICALS USA, INC.]8Current NDC, Legacy NDC, 2 package rows20241114_4ef60c83-ba48-4134-968b-13800ea9b7f2.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rizatriptan BenzoateRIZATRIPTAN BENZOATETeva Pharmaceuticals USA, Inc.4ef60c83-ba48-4134-968b-13800ea9b7f22019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077263
application number: ANDA077263
ndc (product): 0093-7472

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN4ef60c83-ba48-4134-968b-13800ea9b7f28
312840rizatriptan benzoate 5 MG Oral TabletPSN4ef60c83-ba48-4134-968b-13800ea9b7f28
314209rizatriptan 10 MG Oral TabletSCD4ef60c83-ba48-4134-968b-13800ea9b7f28
312840rizatriptan 5 MG Oral TabletSCD4ef60c83-ba48-4134-968b-13800ea9b7f28
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY4ef60c83-ba48-4134-968b-13800ea9b7f28
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSY4ef60c83-ba48-4134-968b-13800ea9b7f28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-7472-19000937472191 in 1 BLISTER PACKHistorical
0093-7472-430009374724318 BLISTER PACK in 1 BOX (0093-7472-43) / 1 TABLET in 1 BLISTER PACK (0093-7472-19) 18 blister pack2013-02-120000-00-00NoNoCurrent