rizatriptan benzoate

Product NDC
68462-467
11-digit product format
684620467
Labeler code
68462
Product ID
68462-467_d0d83e24-265b-4802-96e0-e0d18bef299d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rizatriptan benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA201914
Marketing category
ANDA
Marketing start
2013-07-01
Substance
RIZATRIPTAN BENZOATE
Active strength
5 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
A201914-001RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01
A201914-002RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01

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 UTC2026-02A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01782e0a99824c…
2021-12-28 21:50 UTC2021-12A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201914-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201914-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201914-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201914-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201914-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201914-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201914-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201914-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201914-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201914-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201914-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201914-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201914-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201914-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201914-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201914-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201914-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201914-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201914-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A201914-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201914-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201914-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A201914-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A201914-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201914-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A201914-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201914-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A201914-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201914-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A201914-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A201914-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A201914-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201914-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A201914-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201914-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201914-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201914-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A201914-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201914-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A201914-002AB1ea1830bbd6c7…

Additional Listing Data#

Finished product
Yes
Brand name base
rizatriptan benzoate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIZATRIPTAN BENZOATE5 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
312837Internal RxNorm lookup
312839Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4de33a24-db69-444a-b04d-c69ccba57ab2Available 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8b537454-32b8-7e64-1395-258682782d07Product name520170424
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-467-06rizatriptan benzoate6 in 1 CARTONTABLET, ORALLY DISINTEGRATING613
68462-467-46rizatriptan benzoate1 in 1 POUCHTABLET, ORALLY DISINTEGRATING113
68462-467-46rizatriptan benzoate3 in 1 BOXTABLET, ORALLY DISINTEGRATING313
68462-467-74rizatriptan benzoate4 in 1 CARTONTABLET, ORALLY DISINTEGRATING413
68462-467-74rizatriptan benzoate3 in 1 BOXTABLET, ORALLY DISINTEGRATING313

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-467-06EA - Each68462-467938dc7b2-35c5-4bd0-89bc-09ddbb56ab6712013-08-02
68462-467-46EA - Each68462-4675fc3afcb-9d29-425f-944f-41805b631f7f12017-04-05

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-467RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]13Current NDC, Legacy NDC, 5 package rows20240104_4de33a24-db69-444a-b04d-c69ccba57ab2.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 BENZOATEGlenmark Pharmaceuticals Inc., USA4de33a24-db69-444a-b04d-c69ccba57ab22022-09-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201914
application number: ANDA201914
ndc (product): 68462-467

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN4de33a24-db69-444a-b04d-c69ccba57ab213
312839rizatriptan benzoate 5 MG Disintegrating Oral TabletPSN4de33a24-db69-444a-b04d-c69ccba57ab213
312837rizatriptan 10 MG Disintegrating Oral TabletSCD4de33a24-db69-444a-b04d-c69ccba57ab213
312839rizatriptan 5 MG Disintegrating Oral TabletSCD4de33a24-db69-444a-b04d-c69ccba57ab213
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSY4de33a24-db69-444a-b04d-c69ccba57ab213
312839rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Disintegrating Oral TabletSY4de33a24-db69-444a-b04d-c69ccba57ab213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-467-06684620467066 BOX in 1 CARTON (68462-467-06) / 3 POUCH in 1 BOX (68462-467-46) / 1 BLISTER PACK in 1 POUCH / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK6 box2013-07-010000-00-00NoNoCurrent
68462-467-46684620467461 in 1 POUCHHistorical
68462-467-74684620467744 BOX in 1 CARTON (68462-467-74) / 3 POUCH in 1 BOX / 1 BLISTER PACK in 1 POUCH / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK4 box2013-07-010000-00-00NoNoCurrent