FDA.reportPublic FDA data

SECUADO

Product NDC
68968-0174
11-digit product format
689680174
Labeler code
68968
Product ID
68968-0174_ae8030f1-3ed5-40cf-a726-de4c14ee8c1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ASENAPINE
Dosage form
FILM, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Noven Therapeutics, LLC
Application
NDA212268
Marketing category
NDA
Marketing start
2020-02-12
Substance
ASENAPINE
Active strength
7.6 mg/d
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASENAPINE7.6 mg/d

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJKZ19V908O
Rxcui2261741, 2261750, 2261758, 2265729, 2265732, 2265735

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
5230498f-5ba0-2e92-5ec3-564c02237e72Product name320210607
e1a56ed3-15d0-4970-9174-95c3bde43653Product name120200309

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68968-0174-32025-02-01C16284748780-12cef2736-a476-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use SECUADO ® (asenapine) transdermal system safely and effectively. See full prescribing information for SECUADO ® . SECUADO ® (asenapine) transdermal system Initial U.S. Approval: 2009
68968-0174-72025-02-01C16284748780-12cef2736-a476-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use SECUADO ® (asenapine) transdermal system safely and effectively. See full prescribing information for SECUADO ® . SECUADO ® (asenapine) transdermal system Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68968-0174-3SECUADO1 d in 1 POUCHFILM, EXTENDED RELEASE113
68968-0174-3SECUADO30 in 1 CARTONFILM, EXTENDED RELEASE3013
68968-0174-7SECUADO1 d in 1 POUCHFILM, EXTENDED RELEASE113
68968-0174-7SECUADO7 in 1 CARTONFILM, EXTENDED RELEASE713

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68968-0174-3EA - Each68968-017467ab2763-65a8-4798-9f81-e265742c0fe912020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68968-0174SECUADO (ASENAPINE) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]13Current NDC, Legacy NDC, 4 package rows20250201_685eaf44-5944-4f38-afba-0a4fc0b3462b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2261741asenapine 3.8 MG/Day 24HR Transdermal SystemPSN685eaf44-5944-4f38-afba-0a4fc0b3462b13
2261750asenapine 5.7 MG/Day 24HR Transdermal SystemPSN685eaf44-5944-4f38-afba-0a4fc0b3462b13
2261758asenapine 7.6 MG/Day 24HR Transdermal SystemPSN685eaf44-5944-4f38-afba-0a4fc0b3462b13
2265729SECUADO 3.8 MG/Day 24HR Transdermal SystemPSN685eaf44-5944-4f38-afba-0a4fc0b3462b13
2265732SECUADO 5.7 MG/Day 24HR Transdermal SystemPSN685eaf44-5944-4f38-afba-0a4fc0b3462b13
2265735SECUADO 7.6 MG/Day 24HR Transdermal SystemPSN685eaf44-5944-4f38-afba-0a4fc0b3462b13
226572924 HR asenapine 0.158 MG/HR Transdermal System [Secuado]SBD685eaf44-5944-4f38-afba-0a4fc0b3462b13
226573224 HR asenapine 0.238 MG/HR Transdermal System [Secuado]SBD685eaf44-5944-4f38-afba-0a4fc0b3462b13
226573524 HR asenapine 0.317 MG/HR Transdermal System [Secuado]SBD685eaf44-5944-4f38-afba-0a4fc0b3462b13
226174124 HR asenapine 0.158 MG/HR Transdermal SystemSCD685eaf44-5944-4f38-afba-0a4fc0b3462b13
226175024 HR asenapine 0.238 MG/HR Transdermal SystemSCD685eaf44-5944-4f38-afba-0a4fc0b3462b13
226175824 HR asenapine 0.317 MG/HR Transdermal SystemSCD685eaf44-5944-4f38-afba-0a4fc0b3462b13
226572924 HR Secuado 0.158 MG/HR Transdermal SystemSY685eaf44-5944-4f38-afba-0a4fc0b3462b13
226573224 HR Secuado 0.238 MG/HR Transdermal SystemSY685eaf44-5944-4f38-afba-0a4fc0b3462b13
226573524 HR Secuado 0.317 MG/HR Transdermal SystemSY685eaf44-5944-4f38-afba-0a4fc0b3462b13
2261741asenapine 3.8 MG/Day 24 HR Transdermal PatchSY685eaf44-5944-4f38-afba-0a4fc0b3462b13
2261750asenapine 5.7 MG/Day 24 HR Transdermal PatchSY685eaf44-5944-4f38-afba-0a4fc0b3462b13
2261758asenapine 7.6 MG/Day 24 HR Transdermal PatchSY685eaf44-5944-4f38-afba-0a4fc0b3462b13
2265729Secuado 3.8 MG/Day 24 HR Transdermal SystemSY685eaf44-5944-4f38-afba-0a4fc0b3462b13
2265732Secuado 5.7 MG/Day 24 HR Transdermal SystemSY685eaf44-5944-4f38-afba-0a4fc0b3462b13
2265735Secuado 7.6 MG/Day 24 HR Transdermal SystemSY685eaf44-5944-4f38-afba-0a4fc0b3462b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68968-0174-36896801740330 POUCH in 1 CARTON (68968-0174-3) / 1 d in 1 POUCH30 pouch2020-02-120000-00-00NoNoCurrent
68968-0174-7689680174077 POUCH in 1 CARTON (68968-0174-7) / 1 d in 1 POUCH7 pouch2020-02-120000-00-00NoNoCurrent