SAPHRIS

Orange BookUNIISPLATC N05AH05

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAllergan, Inc.

CountryUS (United States)

ATC codeN05AH05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
0456240210
1 CASE in 1 CARTON (0456-2402-10) / 1 BLISTER PACK in 1 CASE / 10 TABLET in 1 BLISTER PACK
ndc11
0456240260
6 CASE in 1 CARTON (0456-2402-60) / 1 BLISTER PACK in 1 CASE (0456-2402-06) / 10 TABLET in 1 BLISTER PACK
ndc11
0456240263
10 BLISTER PACK in 1 CARTON (0456-2402-63) / 10 TABLET in 1 BLISTER PACK (0456-2402-11)

Annotations

UNII (FDA Substance ID)

CU9463U2E2

ASENAPINE MALEATE

RxCUI 860647

Orange Book

N022117

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "CU9463U2E2",
    "rxcui": "860647",
    "inchikey": "GMDCDXMAFMEDAG-CHHFXETESA-N;GMDCDXMAFMEDAG-TXUHOWFZSA-N",
    "display_name": "ASENAPINE MALEATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBLINGUAL",
  "spl_meta": {
    "5429f134-839f-4ffc-9944-55f51238def8": {
      "match": "brand_token",
      "title": "SAPHRIS (ASENAPINE MALEATE) TABLET [ALLERGAN, INC.]",
      "spl_version": "22",
      "published_date": "2025-12-12"
    }
  },
  "productid": "0456-2402_9827c4dd-ffac-4022-a021-d1b15a364ecd",
  "productndc": "0456-2402",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "022117",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Aug 13, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Aug 13, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "003",
        "approval_date": "Mar 12, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ASENAPINE MALEATE",
  "proprietary_name": "SAPHRIS",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022117",
  "marketing_category": "NDA",
  "nonproprietary_name": "Asenapine Maleate",
  "start_marketing_date": "20141230",
  "active_numerator_strength": "2.5"
}

Related drugs

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