saphris

Generic: asenapine maleate

Labeler: allergan, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name saphris
Generic Name asenapine maleate
Labeler allergan, inc.
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

asenapine maleate 10 mg/1

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 0456-2410
Product ID 0456-2410_9827c4dd-ffac-4022-a021-d1b15a364ecd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022117
Listing Expiration 2026-12-31
Marketing Start 2013-09-30

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04562410
Hyphenated Format 0456-2410

Supplemental Identifiers

RxCUI
859975 859979 859981 859983 1606337 1606490
UNII
CU9463U2E2

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name saphris (source: ndc)
Generic Name asenapine maleate (source: ndc)
Application Number NDA022117 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 CASE in 1 CARTON (0456-2410-10) / 1 BLISTER PACK in 1 CASE / 10 TABLET in 1 BLISTER PACK
  • 6 CASE in 1 CARTON (0456-2410-60) / 1 BLISTER PACK in 1 CASE (0456-2410-06) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

0456-2410-10 1 CASE in 1 CARTON (0456-2410-10) / 1 BLISTER PACK in 1 CASE / 10 TABLET in 1 BLISTER PACK 0456-2410-60 6 CASE in 1 CARTON (0456-2410-60) / 1 BLISTER PACK in 1 CASE (0456-2410-06) / 10 TABLET in 1 BLISTER PACK

Ingredients (1)

asenapine maleate (10 mg/1)

Linked Drug Pages (1)

SAPHRIS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "9827c4dd-ffac-4022-a021-d1b15a364ecd", "openfda": {"unii": ["CU9463U2E2"], "rxcui": ["859975", "859979", "859981", "859983", "1606337", "1606490"], "spl_set_id": ["5429f134-839f-4ffc-9944-55f51238def8"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 CASE in 1 CARTON (0456-2410-10)  / 1 BLISTER PACK in 1 CASE / 10 TABLET in 1 BLISTER PACK", "package_ndc": "0456-2410-10", "marketing_start_date": "20130930"}, {"sample": false, "description": "6 CASE in 1 CARTON (0456-2410-60)  / 1 BLISTER PACK in 1 CASE (0456-2410-06)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "0456-2410-60", "marketing_start_date": "20130930"}], "brand_name": "SAPHRIS", "product_id": "0456-2410_9827c4dd-ffac-4022-a021-d1b15a364ecd", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0456-2410", "generic_name": "Asenapine Maleate", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SAPHRIS", "active_ingredients": [{"name": "ASENAPINE MALEATE", "strength": "10 mg/1"}], "application_number": "NDA022117", "marketing_category": "NDA", "marketing_start_date": "20130930", "listing_expiration_date": "20261231"}