Frovatriptan

Product NDC
69238-1539
11-digit product format
692381539
Labeler code
69238
Product ID
69238-1539_b44b534c-17a5-4a71-a3e5-7d98adb4cdd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Frovatriptan succinate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA211292
Marketing category
ANDA
Marketing start
2018-11-13
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Frovatriptan
Listing expiration
2027-12-31

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
69238-1539-9Frovatriptan9 in 1 BLISTER PACKTABLET, FILM COATED911
69238-1539-9Frovatriptan1 in 1 CARTONTABLET, FILM COATED111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1539-9EA - Each69238-1539f44d5ddb-aadb-417a-893a-4e784c0478aa12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1539FROVATRIPTAN (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]10Current NDC, Legacy NDC, 2 package rows20240718_94b996dc-ddc4-41ce-9a9f-3d91cb187473.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349462frovatriptan succinate 2.5 MG Oral TabletPSN94b996dc-ddc4-41ce-9a9f-3d91cb18747311
349462frovatriptan 2.5 MG Oral TabletSCD94b996dc-ddc4-41ce-9a9f-3d91cb18747311
349462frovatriptan (as frovatriptan succinate 3.91 MG) Oral TabletSY94b996dc-ddc4-41ce-9a9f-3d91cb18747311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1539-9692381539091 BLISTER PACK in 1 CARTON (69238-1539-9) / 9 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2018-11-130000-00-00NoNoCurrent