NDC 51991-358

Asenapine

Asenapine Maleate

Asenapine is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Breckenridge Pharmaceutical, Inc.. The primary component is Asenapine Maleate.

Product ID51991-358_912f1cd3-73b5-405c-84db-6f7a7a32b9ad
NDC51991-358
Product TypeHuman Prescription Drug
Proprietary NameAsenapine
Generic NameAsenapine Maleate
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2021-03-08
Marketing CategoryANDA /
Application NumberANDA205960
Labeler NameBreckenridge Pharmaceutical, Inc.
Substance NameASENAPINE MALEATE
Active Ingredient Strength5 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 51991-358-11

10 BLISTER PACK in 1 BOX (51991-358-11) > 10 TABLET in 1 BLISTER PACK (51991-358-99)
Marketing Start Date2021-03-08
NDC Exclude FlagN
Sample Package?N

Drug Details

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

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
69539-059AsenapineAsenapine
62332-199AsenapineAsenapine
0052-0118SAPHRISAsenapine Maleate
0052-0119SAPHRISAsenapine Maleate
0052-2139SAPHRISAsenapine Maleate
0052-2142SAPHRISAsenapine Maleate
0456-2402SAPHRISAsenapine Maleate
0456-2405SAPHRISAsenapine Maleate
0456-2410SAPHRISAsenapine Maleate
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