FDA.reportPublic FDA data

Asenapine

Product NDC
62332-198
11-digit product format
623320198
Labeler code
62332
Product ID
62332-198_d54a0a82-b197-46eb-9c1d-4e77960d6f60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Asenapine
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA206098
Marketing category
ANDA
Marketing start
2020-12-10
Substance
ASENAPINE
Active strength
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
Asenapine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASENAPINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJKZ19V908O
Rxcui859975, 859981, 1606337

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5230498f-5ba0-2e92-5ec3-564c02237e72Product name320210607
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
e1a56ed3-15d0-4970-9174-95c3bde43653Product name120200309
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-198-10Asenapine10 in 1 BLISTER PACKTABLET1016
62332-198-31Asenapine100 in 1 CARTONTABLET10016
62332-198-31Asenapine10 in 1 BLISTER PACKTABLET1016
62332-198-60Asenapine60 in 1 CARTONTABLET6016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-198-10EA - Each62332-19871bade6e-9aeb-44ae-b723-15607e98b8b012021-01-08
62332-198-31EA - Each62332-198a547edee-b059-45b3-8773-a4151e6f31bd12021-01-08
62332-198-60EA - Each62332-198e0b16506-aacc-4580-8e5c-fa20d0e00bf812021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-198ASENAPINE TABLET [ALEMBIC PHARMACEUTICALS INC.]16Current NDC, Legacy NDC, 4 package rows20250427_16e1cc9f-7699-49ea-b179-acb65e162304.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859975asenapine 10 MG Sublingual TabletPSN16e1cc9f-7699-49ea-b179-acb65e16230416
1606337asenapine 2.5 MG Sublingual TabletPSN16e1cc9f-7699-49ea-b179-acb65e16230416
859981asenapine 5 MG Sublingual TabletPSN16e1cc9f-7699-49ea-b179-acb65e16230416
859975asenapine 10 MG Sublingual TabletSCD16e1cc9f-7699-49ea-b179-acb65e16230416
1606337asenapine 2.5 MG Sublingual TabletSCD16e1cc9f-7699-49ea-b179-acb65e16230416
859981asenapine 5 MG Sublingual TabletSCD16e1cc9f-7699-49ea-b179-acb65e16230416
859975asenapine (as asenapine maleate) 10 MG Sublingual TabletSY16e1cc9f-7699-49ea-b179-acb65e16230416
1606337asenapine (as asenapine maleate) 2.5 MG Sublingual TabletSY16e1cc9f-7699-49ea-b179-acb65e16230416
859981asenapine (as asenapine maleate) 5 MG Sublingual TabletSY16e1cc9f-7699-49ea-b179-acb65e16230416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-198-106233201981010 in 1 BLISTER PACKHistorical
62332-198-3162332019831100 BLISTER PACK in 1 CARTON (62332-198-31) / 10 TABLET in 1 BLISTER PACK100 blister pack2020-12-100000-00-00NoNoCurrent
62332-198-606233201986060 BLISTER PACK in 1 CARTON (62332-198-60) / 10 TABLET in 1 BLISTER PACK (62332-198-10) 60 blister pack2020-12-100000-00-00NoNoCurrent