NDC 59762-2888

Asenapine

Asenapine Maleate

Asenapine is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Greenstone Llc. The primary component is Asenapine Maleate.

Product ID59762-2888_e60330bc-61c8-4748-87ed-8335195ac583
NDC59762-2888
Product TypeHuman Prescription Drug
Proprietary NameAsenapine
Generic NameAsenapine Maleate
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2020-05-01
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA022117
Labeler NameGreenstone LLC
Substance NameASENAPINE MALEATE
Active Ingredient Strength10 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 59762-2888-6

6 BLISTER PACK in 1 BOX (59762-2888-6) > 10 TABLET in 1 BLISTER PACK
Marketing Start Date2020-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59762-2888-6 [59762288806]

Asenapine TABLET
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA022117
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-01

Drug Details

Active Ingredients

IngredientStrength
ASENAPINE MALEATE10 mg/1

Pharmacological Class

  • Atypical Antipsychotic [EPC]

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
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.