rizatriptan benzoate

Product NDC
68462-468
Requested package NDC
68462-468-06
11-digit product format
684620468
Labeler code
68462
Product ID
68462-468_120ff156-182f-41d2-82a1-f9ff7fd412c6
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
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68462-46868462-468-06DDiscontinued by firm2026-11-12

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01c2088c7a36db…
2026-10-15 13:18:302026-09A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01c2088c7a36db…
2026-09-14 22:38:342026-08A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-0184e616aacf4f…
2026-08-18 06:07:402026-07A201914-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A201914-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01caaa826d4ba7…
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…

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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
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
68462-468-06rizatriptan benzoate6 in 1 CARTONTABLET, ORALLY DISINTEGRATING613
68462-468-46rizatriptan benzoate1 in 1 POUCHTABLET, ORALLY DISINTEGRATING113
68462-468-46rizatriptan benzoate3 in 1 BOXTABLET, ORALLY DISINTEGRATING313
68462-468-74rizatriptan benzoate3 in 1 BOXTABLET, ORALLY DISINTEGRATING313
68462-468-74rizatriptan benzoate4 in 1 CARTONTABLET, ORALLY DISINTEGRATING413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-468-06EA - Each68462-4688ec2e906-69a4-4884-ad4a-dc040669f2a912013-08-02
68462-468-46EA - Each68462-46802cfb728-e4ae-47ee-a2ff-c3b36395887712017-03-06

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-468RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]13Current NDC, Legacy NDC, 5 package rows20240104_4de33a24-db69-444a-b04d-c69ccba57ab2.zip

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
68462-468-06684620468066 BOX in 1 CARTON (68462-468-06) > 3 POUCH in 1 BOX (68462-468-46) > 1 BLISTER PACK in 1 POUCH > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK6 box2013-07-010000-00-00NoNoCurrent