Asenapine

Orange BookUNIISPLATC N05AH05

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

Identification

ManufacturerBreckenridge Pharmaceutical, Inc.

CountryUS (United States)

ATC codeN05AH05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5199135911
10 BLISTER PACK in 1 BOX (51991-359-11) / 10 TABLET in 1 BLISTER PACK (51991-359-99)
ndc11
5199135960
6 BLISTER PACK in 1 BOX (51991-359-60) / 10 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

CU9463U2E2

ASENAPINE MALEATE

RxCUI 860647

Orange Book

A205960

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": {
    "3512687b-d1c7-45c4-8822-3a2ad53575a5": {
      "match": "brand_token",
      "title": "ASENAPINE TABLET [SIGMAPHARM LABORATORIES, LLC]",
      "spl_version": "11",
      "published_date": "2025-11-26"
    }
  },
  "productid": "51991-359_b48a6c73-5ff9-46da-ae10-6fc0ced6afc7",
  "productndc": "51991-359",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205960",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Dec 10, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Dec 10, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "003",
        "approval_date": "Mar 8, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ASENAPINE MALEATE",
  "proprietary_name": "Asenapine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205960",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ASENAPINE MALEATE",
  "start_marketing_date": "20210308",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N05AH05.

Access this data programmatically

Query Asenapine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs