NDC 46708-544

Asenapine

Asenapine

Asenapine is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Asenapine.

Product ID46708-544_728cb889-8925-4412-9dc6-23996ea0d3c7
NDC46708-544
Product TypeHuman Prescription Drug
Proprietary NameAsenapine
Generic NameAsenapine
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2021-07-20
Marketing CategoryANDA /
Application NumberANDA206098
Labeler NameAlembic Pharmaceuticals Limited
Substance NameASENAPINE
Active Ingredient Strength3 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 46708-544-31

100 BLISTER PACK in 1 CARTON (46708-544-31) > 10 TABLET in 1 BLISTER PACK
Marketing Start Date2021-07-20
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Asenapine" or generic name "Asenapine"

NDCBrand NameGeneric Name
42794-016ASENAPINEASENAPINE
42794-017ASENAPINEASENAPINE
46708-198AsenapineAsenapine
46708-199AsenapineAsenapine
46708-544AsenapineAsenapine
51991-358AsenapineASENAPINE MALEATE
51991-359AsenapineASENAPINE MALEATE
51991-360AsenapineASENAPINE MALEATE
51991-361AsenapineASENAPINE MALEATE
51991-928AsenapineASENAPINE MALEATE
59762-1091Asenapineasenapine maleate
59762-2012Asenapineasenapine maleate
59762-2888Asenapineasenapine maleate
62332-198AsenapineAsenapine
62332-199AsenapineAsenapine
62332-544AsenapineAsenapine
69539-059AsenapineAsenapine
68968-0172SECUADOASENAPINE
68968-0173SECUADOASENAPINE
68968-0174SECUADOASENAPINE
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