SECUADO

Orange BookUNIISPLATC N05AH05

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

Identification

ManufacturerNoven Therapeutics, LLC

CountryUS (United States)

ATC codeN05AH05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6896801723
30 POUCH in 1 CARTON (68968-0172-3) / 1 d in 1 POUCH
ndc11
6896801727
7 POUCH in 1 CARTON (68968-0172-7) / 1 d in 1 POUCH

Annotations

UNII (FDA Substance ID)

JKZ19V908O

ASENAPINE

RxCUI 784649

Orange Book

N212268

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "JKZ19V908O",
    "rxcui": "784649",
    "inchikey": "VSWBSWWIRNCQIJ-HUUCEWRRSA-N;VSWBSWWIRNCQIJ-GJZGRUSLSA-N",
    "display_name": "ASENAPINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TRANSDERMAL",
  "spl_meta": {
    "685eaf44-5944-4f38-afba-0a4fc0b3462b": {
      "match": "brand_token",
      "title": "SECUADO (ASENAPINE) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]",
      "spl_version": "13",
      "published_date": "2025-02-03"
    }
  },
  "productid": "68968-0172_ae8030f1-3ed5-40cf-a726-de4c14ee8c1c",
  "productndc": "68968-0172",
  "dosage_form": "FILM, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "212268",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3.8MG/24HR",
        "product_no": "001",
        "approval_date": "Oct 11, 2019"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5.7MG/24HR",
        "product_no": "002",
        "approval_date": "Oct 11, 2019"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "7.6MG/24HR",
        "product_no": "003",
        "approval_date": "Oct 11, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ASENAPINE",
  "proprietary_name": "SECUADO",
  "active_ingred_unit": "mg/d",
  "application_number": "NDA212268",
  "marketing_category": "NDA",
  "nonproprietary_name": "ASENAPINE",
  "start_marketing_date": "20200212",
  "active_numerator_strength": "3.8"
}

Related drugs

Other records sharing ATC code N05AH05.

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