frovatriptan succinate

Product NDC
68462-694
11-digit product format
684620694
Labeler code
68462
Product ID
68462-694_798e763f-c8b2-401b-b0a4-9b5da3241b62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
frovatriptan succinate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA204730
Marketing category
ANDA
Marketing start
2016-03-11
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 succinate
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-694-97frovatriptan succinate1 in 1 CARTONTABLET, FILM COATED17
68462-694-97frovatriptan succinate9 in 1 BLISTER PACKTABLET, FILM COATED97

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-694-97EA - Each68462-694b5a84c7a-bdc9-4ed3-80e0-7935bf0f89b512016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-694FROVATRIPTAN SUCCINATE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]6Current NDC, Legacy NDC, 2 package rows20240104_03a58215-dba7-4f63-8b98-d74d054a574a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349462frovatriptan succinate 2.5 MG Oral TabletPSN03a58215-dba7-4f63-8b98-d74d054a574a7
349462frovatriptan 2.5 MG Oral TabletSCD03a58215-dba7-4f63-8b98-d74d054a574a7
349462frovatriptan (as frovatriptan succinate 3.91 MG) Oral TabletSY03a58215-dba7-4f63-8b98-d74d054a574a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-694-97684620694971 BLISTER PACK in 1 CARTON (68462-694-97) / 9 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2016-03-110000-00-00NoNoCurrent