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

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