FROVA

Product NDC
63481-025
11-digit product format
634810025
Labeler code
63481
Product ID
63481-025_492b9727-53ae-47e2-a832-08bb7930b5bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
frovatriptan succinate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Endo Pharmaceuticals, Inc.
Application
NDA021006
Marketing category
NDA
Marketing start
2001-11-08
Marketing end
0000-00-00
Substance
FROVATRIPTAN SUCCINATE
Active strength
3 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
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63481-025DDiscontinued by firm2026-08-10
excluded packagepackage63481-02563481-025-09DDiscontinued by firm2026-08-10
excluded packagepackage63481-02563481-025-12DDiscontinued by firm2026-08-10

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021006-001FROVAFROVATRIPTAN SUCCINATEEQ 2.5MG BASETABLET / ORALRLD2001-11-08

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-083f01610625f2…
2019-09-15 20:21 UTC2019-09N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021006-001FROVAEQ 2.5MG BASETABLET / ORALABRLD, RS2001-11-08cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021006-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021006-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021006-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021006-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021006-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021006-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021006-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021006-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021006-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021006-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021006-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021006-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021006-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021006-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021006-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021006-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021006-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021006-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021006-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021006-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021006-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021006-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021006-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021006-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021006-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021006-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021006-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021006-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021006-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021006-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021006-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021006-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021006-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021006-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021006-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021006-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021006-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021006-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021006-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021006-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5c115a0d-7f70-66e8-a67a-15f7b6effe55Product name520260128

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63481-025-09EA - Each63481-025b84e33f0-cfb6-48bc-98bb-95332b5a669f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FROVATRIPTAN SUCCINATEACTIVE INGREDIENTD28J6W18HYFROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [ENDO PHARMACEUTICALS INC.]14
FROVATRIPTANACTIVE MOIETYH82Q2D5WA7FROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [ENDO PHARMACEUTICALS INC.]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [ENDO PHARMACEUTICALS INC.]14
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [ENDO PHARMACEUTICALS INC.]14
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GFROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [ENDO PHARMACEUTICALS INC.]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [ENDO PHARMACEUTICALS INC.]14
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746FROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [ENDO PHARMACEUTICALS INC.]14
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [ENDO PHARMACEUTICALS INC.]14
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [ENDO PHARMACEUTICALS INC.]14
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [ENDO PHARMACEUTICALS INC.]14
TRIACETININACTIVE INGREDIENTXHX3C3X673FROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [ENDO PHARMACEUTICALS INC.]14
FROVATRIPTAN SUCCINATEACTIVE INGREDIENTD28J6W18HYFROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [STAT RX USA LLC]1
FROVATRIPTANACTIVE MOIETYH82Q2D5WA7FROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [STAT RX USA LLC]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOFROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [STAT RX USA LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GFROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [STAT RX USA LLC]1
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746FROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [STAT RX USA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [STAT RX USA LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [STAT RX USA LLC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673FROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63481-025FROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [ENDO USA, INC.]20Legacy NDC20240913_c0703630-9ce8-4259-841e-71fd2019fa66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
352058Frova 2.5 MG Oral TabletPSN8ce8bf0a-8b21-41a5-bbea-71302312c2c51
349462frovatriptan succinate 2.5 MG Oral TabletPSN8ce8bf0a-8b21-41a5-bbea-71302312c2c51
352058frovatriptan 2.5 MG Oral Tablet [Frova]SBD8ce8bf0a-8b21-41a5-bbea-71302312c2c51
349462frovatriptan 2.5 MG Oral TabletSCD8ce8bf0a-8b21-41a5-bbea-71302312c2c51
352058Frova 2.5 MG (as frovatriptan succinate 3.91 MG) Oral TabletSY8ce8bf0a-8b21-41a5-bbea-71302312c2c51
352058Frova 2.5 MG Oral TabletSY8ce8bf0a-8b21-41a5-bbea-71302312c2c51
349462frovatriptan (as frovatriptan succinate 3.91 MG) Oral TabletSY8ce8bf0a-8b21-41a5-bbea-71302312c2c51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63481-025-09634810025091 BLISTER PACK in 1 CARTON (63481-025-09) > 9 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2001-11-080000-00-00NoNoCurrent