FDA.reportPublic FDA data

ASENAPINE

Product NDC
42794-016
11-digit product format
427940016
Labeler code
42794
Product ID
42794-016_446e6925-ccb1-e388-e063-6294a90aa5de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ASENAPINE
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Sigmapharm Laboratories, LLC
Application
ANDA206107
Marketing category
ANDA
Marketing start
2020-12-14
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
5230498f-5ba0-2e92-5ec3-564c02237e72Product name320210607
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e1a56ed3-15d0-4970-9174-95c3bde43653Product name120200309
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42794-016-08ASENAPINE30 in 1 BOTTLE, PLASTICTABLET3011
42794-016-10ASENAPINE60 in 1 BOTTLE, PLASTICTABLET6011
42794-016-22ASENAPINE10 in 1 BOTTLE, PLASTICTABLET1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42794-016ASENAPINE TABLET [SIGMAPHARM LABORATORIES, LLC]10Current NDC, Legacy NDC, 3 package rows20230111_3512687b-d1c7-45c4-8822-3a2ad53575a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859975asenapine 10 MG Sublingual TabletPSN3512687b-d1c7-45c4-8822-3a2ad53575a511
859981asenapine 5 MG Sublingual TabletPSN3512687b-d1c7-45c4-8822-3a2ad53575a511
859975asenapine 10 MG Sublingual TabletSCD3512687b-d1c7-45c4-8822-3a2ad53575a511
859981asenapine 5 MG Sublingual TabletSCD3512687b-d1c7-45c4-8822-3a2ad53575a511
859975asenapine (as asenapine maleate) 10 MG Sublingual TabletSY3512687b-d1c7-45c4-8822-3a2ad53575a511
859981asenapine (as asenapine maleate) 5 MG Sublingual TabletSY3512687b-d1c7-45c4-8822-3a2ad53575a511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42794-016-084279400160830 TABLET in 1 BOTTLE, PLASTIC (42794-016-08) 30 tablet2020-12-140000-00-00NoNoCurrent
42794-016-104279400161060 TABLET in 1 BOTTLE, PLASTIC (42794-016-10) 60 tablet2020-12-140000-00-00NoNoCurrent
42794-016-224279400162210 TABLET in 1 BOTTLE, PLASTIC (42794-016-22) 10 tablet2020-12-140000-00-00NoNoCurrent