RIZATRIPTAN Benzoate

Product NDC
51991-363
11-digit product format
519910363
Labeler code
51991
Product ID
51991-363_24ffdbe7-4f42-4277-942a-9edd765df282
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RIZATRIPTAN Benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA203478
Marketing category
ANDA
Marketing start
2013-07-01
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51991-363DDiscontinued by firm2026-08-17
excluded packagepackage51991-36351991-363-78DDiscontinued by firm2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct51991-363DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51991-36351991-363-78DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203478-001RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01
A203478-002RIZATRIPTAN 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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORAL2013-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203478-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203478-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2013-07-01bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203478-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203478-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203478-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203478-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203478-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203478-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203478-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203478-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203478-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203478-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203478-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203478-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203478-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203478-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203478-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203478-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203478-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203478-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203478-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203478-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203478-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203478-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203478-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203478-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203478-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203478-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203478-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203478-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203478-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203478-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203478-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203478-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203478-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203478-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203478-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203478-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203478-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A203478-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203478-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A203478-002AB18869cabd3fbd…

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-363-78EA - Each51991-363f02beeff-1e5f-4d6a-841f-675e4258f83412013-08-02
51991-363-99EA - Each51991-363a8a82ad7-25f8-4aa7-a121-e1344533a8ca12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
RIZATRIPTANACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
GLYCINEINACTIVE INGREDIENTTE7660XO1CRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
MANNITOLINACTIVE INGREDIENT3OWL53L36ARIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
MONOSODIUM CITRATEINACTIVE INGREDIENT68538UP9SERIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1
RIZATRIPTANACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1
GLYCINEINACTIVE INGREDIENTTE7660XO1CRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ARIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1
MONOSODIUM CITRATEINACTIVE INGREDIENT68538UP9SERIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-363RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]10Legacy NDC20240327_cd03ee57-0fb8-4ddf-88e8-b1f953a593f8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-363-78519910363783 BLISTER PACK in 1 CARTON (51991-363-78) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (51991-363-99) 3 blister pack2013-07-010000-00-00NoNoCurrent