Asenapine

Orange BookUNIISPLATC N05AH05

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

Identification

ManufacturerMSN LABORATORIES PRIVATE LIMITED

CountryUS (United States)

ATC codeN05AH05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6953905834
60 TABLET in 1 BOX (69539-058-34)

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": "69539-058_0c0d566e-5315-4e29-a207-5f2eb75910f0",
  "productndc": "69539-058",
  "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": "20210827",
  "active_numerator_strength": "5"
}

Related drugs

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