Asenapine

Product NDC
59762-2012
11-digit product format
597622012
Labeler code
59762
Product ID
59762-2012_fb1d5c85-98bc-4d28-a7f4-6c363269042e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
asenapine maleate
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Greenstone LLC
Application
NDA022117
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-05-01
Marketing end
0000-00-00
Substance
ASENAPINE MALEATE
Active strength
5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-2012-6EA - Each59762-20128fdaadaf-53b0-4f94-9475-6e204e9405cc12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-2012ASENAPINE (ASENAPINE MALEATE) TABLET [GREENSTONE LLC]3Legacy NDC20231019_86a40942-8d6b-478c-995f-3c346b197463.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-2012-6597622012066 BLISTER PACK in 1 BOX (59762-2012-6) > 10 TABLET in 1 BLISTER PACK6 blister pack2020-05-010000-00-00NoNoCurrent