FROVATRIPTAN

Product NDC
50742-299
11-digit product format
507420299
Labeler code
50742
Product ID
50742-299_447a8874-8a78-84a6-e063-6294a90aa3b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
frovatriptan succinate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA213891
Marketing category
ANDA
Marketing start
2022-07-22
Substance
FROVATRIPTAN SUCCINATE
Active strength
2.5 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FROVATRIPTAN SUCCINATE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD28J6W18HY
Rxcui349462

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50742-299-09FROVATRIPTAN1 in 1 CARTONTABLET, FILM COATED16
50742-299-09FROVATRIPTAN9 in 1 BLISTER PACKTABLET, FILM COATED96

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-299-09EA - Each50742-299e69a60e1-8277-4958-8055-1d2964bc5c4812022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-299FROVATRIPTAN (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 2 package rows20241215_92c91060-c06e-4a8a-b586-a3fb25c33433.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349462frovatriptan succinate 2.5 MG Oral TabletPSN92c91060-c06e-4a8a-b586-a3fb25c334336
349462frovatriptan 2.5 MG Oral TabletSCD92c91060-c06e-4a8a-b586-a3fb25c334336
349462frovatriptan (as frovatriptan succinate 3.91 MG) Oral TabletSY92c91060-c06e-4a8a-b586-a3fb25c334336

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-299-09507420299091 BLISTER PACK in 1 CARTON (50742-299-09) / 9 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2022-07-220000-00-00NoNoCurrent