Asenapine Maleate

Product NDC
64330-625
11-digit product format
643300625
Labeler code
64330
Product ID
64330-625_055ddb13-3143-49f8-a771-06c7bea5a30a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Asenapine Maleate
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Centaur Pharmaceuticals Private Limited
Application
ANDA205960
Marketing category
ANDA
Marketing start
2020-12-10
Marketing end
0000-00-00
Substance
ASENAPINE MALEATE
Active strength
3 1/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64330-625-016433006250160 TABLET in 1 BOX (64330-625-01) 60 tablet2020-12-100000-00-00NoNoCurrent