FDA.reportPublic FDA data

TASCENSO ODT

Product NDC
70709-065
11-digit product format
707090065
Labeler code
70709
Product ID
70709-065_eb717a3b-e703-4637-83c7-fccdecbac199
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fingolimod Lauryl Sulfate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Cycle Pharmaceuticals Ltd
Application
NDA214962
Marketing category
NDA
Marketing start
2023-02-01
Substance
FINGOLIMOD LAURYL SULFATE
Active strength
.5 mg/1
Pharmacologic classes
Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FINGOLIMOD LAURYL SULFATE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ3HZQ9BE2S
Rxcui2610295, 2610302, 2626383, 2626385

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
665f4aef-df96-42b3-97d1-5971737de3dcProduct name920250121
6b6bc7ea-a5a8-4e5e-b81d-4b6b4cbe6f45Product name120230919

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70709-065-30TASCENSO ODT3 in 1 CARTONTABLET, ORALLY DISINTEGRATING38
70709-065-30TASCENSO ODT10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70709-065-30EA - Each70709-0652e29e457-54eb-49bf-ae5e-51f546400fe612023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70709-065TASCENSO ODT (FINGOLIMOD LAURYL SULFATE) TABLET, ORALLY DISINTEGRATING [CYCLE PHARMACEUTICALS LTD]7Current NDC, 2 package rows20250327_bf8e7f89-ea09-43c7-a7eb-e44724350721.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2610295fingolimod 0.25 MG Disintegrating Oral TabletPSNbf8e7f89-ea09-43c7-a7eb-e447243507218
2626383fingolimod 0.5 MG Disintegrating Oral TabletPSNbf8e7f89-ea09-43c7-a7eb-e447243507218
2610302Tascenso ODT 0.25 MG Disintegrating Oral TabletPSNbf8e7f89-ea09-43c7-a7eb-e447243507218
2626385Tascenso ODT 0.5 MG Disintegrating Oral TabletPSNbf8e7f89-ea09-43c7-a7eb-e447243507218
2610302fingolimod 0.25 MG Disintegrating Oral Tablet [Tascenso]SBDbf8e7f89-ea09-43c7-a7eb-e447243507218
2626385fingolimod 0.5 MG Disintegrating Oral Tablet [Tascenso]SBDbf8e7f89-ea09-43c7-a7eb-e447243507218
2610295fingolimod 0.25 MG Disintegrating Oral TabletSCDbf8e7f89-ea09-43c7-a7eb-e447243507218
2626383fingolimod 0.5 MG Disintegrating Oral TabletSCDbf8e7f89-ea09-43c7-a7eb-e447243507218
2610295fingolimod 0.25 MG (as fingolimod lauryl sulfate 0.47 MG) Disintegrating Oral TabletSYbf8e7f89-ea09-43c7-a7eb-e447243507218
2610302Tascenso 0.25 MG (as fingolimod lauryl sulfate 0.47 MG) Disintegrating Oral TabletSYbf8e7f89-ea09-43c7-a7eb-e447243507218
2626385Tascenso 0.5 MG Disintegrating Oral TabletSYbf8e7f89-ea09-43c7-a7eb-e447243507218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70709-065-30707090065303 BLISTER PACK in 1 CARTON (70709-065-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2023-02-01NoNoHistorical