FDA.reportPublic FDA data

SAPHRIS

Product NDC
0456-2402
11-digit product format
004562402
Labeler code
0456
Product ID
0456-2402_9827c4dd-ffac-4022-a021-d1b15a364ecd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Asenapine Maleate
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Allergan, Inc.
Application
NDA022117
Marketing category
NDA
Marketing start
2014-12-30
Substance
ASENAPINE MALEATE
Active strength
2.5 mg/1
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
SAPHRIS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASENAPINE MALEATE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCU9463U2E2
Rxcui859975, 859979, 859981, 859983, 1606337, 1606490

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5230498f-5ba0-2e92-5ec3-564c02237e72Product name320210607
e1a56ed3-15d0-4970-9174-95c3bde43653Product name120200309

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0456-2402-06SAPHRIS10 in 1 BLISTER PACKTABLET1022
0456-2402-06SAPHRIS1 in 1 CASETABLET122
0456-2402-10SAPHRIS1 in 1 CARTONTABLET122
0456-2402-10SAPHRIS1 in 1 CASETABLET122
0456-2402-11SAPHRIS10 in 1 BLISTER PACKTABLET1022
0456-2402-60SAPHRIS6 in 1 CARTONTABLET622
0456-2402-63SAPHRIS10 in 1 CARTONTABLET1022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0456-2402-06EA - Each0456-2402c7b64a30-4591-4c09-b5b3-f5c7a534208e12016-01-13
0456-2402-60EA - Each0456-24026caf8896-1f4a-4caa-99ff-791768991bbe12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Asenapine MaleateACTIVE INGREDIENTCU9463U2E2SAPHRIS (ASENAPINE MALEATE) TABLET [FOREST LABORATORIES, INC.]5
AsenapineACTIVE MOIETYJKZ19V908OSAPHRIS (ASENAPINE MALEATE) TABLET [FOREST LABORATORIES, INC.]5
gelatinINACTIVE INGREDIENT2G86QN327LSAPHRIS (ASENAPINE MALEATE) TABLET [FOREST LABORATORIES, INC.]5
mannitolINACTIVE INGREDIENT3OWL53L36ASAPHRIS (ASENAPINE MALEATE) TABLET [FOREST LABORATORIES, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0456-2402SAPHRIS (ASENAPINE MALEATE) TABLET [ALLERGAN, INC.]21Current NDC, Legacy NDC, 7 package rows20250212_5429f134-839f-4ffc-9944-55f51238def8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859975asenapine 10 MG Sublingual TabletPSN5429f134-839f-4ffc-9944-55f51238def822
1606337asenapine 2.5 MG Sublingual TabletPSN5429f134-839f-4ffc-9944-55f51238def822
859981asenapine 5 MG Sublingual TabletPSN5429f134-839f-4ffc-9944-55f51238def822
859979Saphris 10 MG Sublingual TabletPSN5429f134-839f-4ffc-9944-55f51238def822
1606490Saphris 2.5 MG Sublingual TabletPSN5429f134-839f-4ffc-9944-55f51238def822
859983Saphris 5 MG Sublingual TabletPSN5429f134-839f-4ffc-9944-55f51238def822
859979asenapine 10 MG Sublingual Tablet [Saphris]SBD5429f134-839f-4ffc-9944-55f51238def822
1606490asenapine 2.5 MG Sublingual Tablet [Saphris]SBD5429f134-839f-4ffc-9944-55f51238def822
859983asenapine 5 MG Sublingual Tablet [Saphris]SBD5429f134-839f-4ffc-9944-55f51238def822
859975asenapine 10 MG Sublingual TabletSCD5429f134-839f-4ffc-9944-55f51238def822
1606337asenapine 2.5 MG Sublingual TabletSCD5429f134-839f-4ffc-9944-55f51238def822
859981asenapine 5 MG Sublingual TabletSCD5429f134-839f-4ffc-9944-55f51238def822
859975asenapine (as asenapine maleate) 10 MG Sublingual TabletSY5429f134-839f-4ffc-9944-55f51238def822
1606337asenapine (as asenapine maleate) 2.5 MG Sublingual TabletSY5429f134-839f-4ffc-9944-55f51238def822
859981asenapine (as asenapine maleate) 5 MG Sublingual TabletSY5429f134-839f-4ffc-9944-55f51238def822
859979Saphris 10 MG Sublingual TabletSY5429f134-839f-4ffc-9944-55f51238def822
1606490Saphris 2.5 MG (as asenapine maleate) Sublingual TabletSY5429f134-839f-4ffc-9944-55f51238def822
1606490Saphris 2.5 MG Sublingual TabletSY5429f134-839f-4ffc-9944-55f51238def822
859983Saphris 5 MG Sublingual TabletSY5429f134-839f-4ffc-9944-55f51238def822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0456-2402-060045624020610 in 1 BLISTER PACKHistorical
0456-2402-10004562402101 CASE in 1 CARTON (0456-2402-10) / 1 BLISTER PACK in 1 CASE / 10 TABLET in 1 BLISTER PACK1 case2014-12-300000-00-00YesNoCurrent
0456-2402-110045624021110 in 1 BLISTER PACKHistorical
0456-2402-60004562402606 CASE in 1 CARTON (0456-2402-60) / 1 BLISTER PACK in 1 CASE (0456-2402-06) / 10 TABLET in 1 BLISTER PACK6 case2014-12-300000-00-00NoNoCurrent
0456-2402-630045624026310 BLISTER PACK in 1 CARTON (0456-2402-63) / 10 TABLET in 1 BLISTER PACK (0456-2402-11) 10 blister pack2014-12-300000-00-00NoNoCurrent