NDC 42794-016

ASENAPINE

Asenapine

ASENAPINE is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Sigmapharm Laboratories, Llc. The primary component is Asenapine.

Product ID42794-016_b685df1d-803c-44cf-e053-2995a90a38cd
NDC42794-016
Product TypeHuman Prescription Drug
Proprietary NameASENAPINE
Generic NameAsenapine
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2020-12-14
Marketing CategoryANDA / ANDA
Application NumberANDA206107
Labeler NameSigmapharm Laboratories, LLC
Substance NameASENAPINE
Active Ingredient Strength5 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 42794-016-08

30 TABLET in 1 BOTTLE, PLASTIC (42794-016-08)
Marketing Start Date2020-12-14
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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