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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N214962-001TASCENSO ODTFINGOLIMOD LAURYL SULFATEEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD2021-12-23
N214962-002TASCENSO ODTFINGOLIMOD LAURYL SULFATEEQ 0.5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2022-12-09

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N214962-001105559022036-01-19U-32682022-01-11
N214962-001109258292036-01-19Drug product2022-01-11
N214962-00199251382036-01-19Drug product2022-01-11
N214962-002105559022036-01-19U-34932022-12-16
N214962-002109258292036-01-19Drug product2022-12-16
N214962-00299251382036-01-19Drug product2022-12-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD2021-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214962-002TASCENSO ODTEQ 0.5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2022-12-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD2021-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214962-002TASCENSO ODTEQ 0.5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2022-12-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD2021-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214962-002TASCENSO ODTEQ 0.5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2022-12-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD2021-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214962-002TASCENSO ODTEQ 0.5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2022-12-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD2021-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214962-002TASCENSO ODTEQ 0.5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2022-12-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD2021-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214962-002TASCENSO ODTEQ 0.5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2022-12-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD2021-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214962-002TASCENSO ODTEQ 0.5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2022-12-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD2021-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214962-002TASCENSO ODTEQ 0.5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2022-12-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD2021-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214962-002TASCENSO ODTEQ 0.5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2022-12-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD2021-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N214962-002TASCENSO ODTEQ 0.5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2022-12-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD2021-12-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214962-002TASCENSO ODTEQ 0.5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2022-12-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD2021-12-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214962-002TASCENSO ODTEQ 0.5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2022-12-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD2021-12-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214962-002TASCENSO ODTEQ 0.5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2022-12-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD2021-12-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05N214962-002TASCENSO ODTEQ 0.5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2022-12-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2021-12-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2021-12-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2021-12-234b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2021-12-23bb7c543d1eb4…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD2021-12-236a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N214962-002TASCENSO ODTEQ 0.5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2022-12-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD2021-12-231c564ffb4f44…
2024-02-18 07:12 UTC2024-02N214962-002TASCENSO ODTEQ 0.5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2022-12-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD2021-12-23ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N214962-002TASCENSO ODTEQ 0.5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2022-12-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N214962-001TASCENSO ODTEQ 0.25MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD2021-12-23a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N214962-002TASCENSO ODTEQ 0.5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD, RS2022-12-09a72a2bbeb626…

Observed Orange Book patent history#

Patent history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N214962-001105559022036-01-19U-32682022-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214962-001109258292036-01-19Drug product2022-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214962-00199251382036-01-19Drug product2022-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214962-002105559022036-01-19U-34932022-12-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214962-002109258292036-01-19Drug product2022-12-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214962-00299251382036-01-19Drug product2022-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214962-001105559022036-01-19U-32682022-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214962-001109258292036-01-19Drug product2022-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214962-00199251382036-01-19Drug product2022-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214962-002105559022036-01-19U-34932022-12-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214962-002109258292036-01-19Drug product2022-12-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214962-00299251382036-01-19Drug product2022-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N214962-001105559022036-01-19U-32682022-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214962-001109258292036-01-19Drug product2022-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214962-00199251382036-01-19Drug product2022-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214962-002105559022036-01-19U-34932022-12-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214962-002109258292036-01-19Drug product2022-12-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214962-00299251382036-01-19Drug product2022-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214962-001105559022036-01-19U-32682022-01-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214962-001109258292036-01-19Drug product2022-01-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214962-00199251382036-01-19Drug product2022-01-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214962-002105559022036-01-19U-34932022-12-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214962-002109258292036-01-19Drug product2022-12-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214962-00299251382036-01-19Drug product2022-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214962-001105559022036-01-19U-32682022-01-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214962-001109258292036-01-19Drug product2022-01-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214962-00199251382036-01-19Drug product2022-01-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214962-002105559022036-01-19U-34932022-12-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214962-002109258292036-01-19Drug product2022-12-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214962-00299251382036-01-19Drug product2022-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214962-001105559022036-01-19U-32682022-01-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214962-001109258292036-01-19Drug product2022-01-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214962-00199251382036-01-19Drug product2022-01-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214962-002105559022036-01-19U-34932022-12-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214962-002109258292036-01-19Drug product2022-12-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214962-00299251382036-01-19Drug product2022-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214962-001105559022036-01-19U-32682022-01-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214962-001109258292036-01-19Drug product2022-01-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214962-00199251382036-01-19Drug product2022-01-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214962-002105559022036-01-19U-34932022-12-162680178bc6a6…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J3HZQ9BE2SInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2610295Internal RxNorm lookup
2610302Internal RxNorm lookup
2626383Internal RxNorm lookup
2626385Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bf8e7f89-ea09-43c7-a7eb-e44724350721Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TASCENSO ODTFINGOLIMOD LAURYL SULFATECycle Pharmaceuticals Ltdbf8e7f89-ea09-43c7-a7eb-e447243507212026-01-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 214962
application number: NDA214962
ndc (product): 70709-065

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 pack2023-02-01NoNoCurrent