Asenapine

Orange BookUNIISPLATC N05AH05

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

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC codeN05AH05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4670819931
100 BLISTER PACK in 1 CARTON (46708-199-31) / 10 TABLET in 1 BLISTER PACK
ndc11
4670819960
60 BLISTER PACK in 1 CARTON (46708-199-60) / 10 TABLET in 1 BLISTER PACK (46708-199-10)

Annotations

UNII (FDA Substance ID)

JKZ19V908O

ASENAPINE

RxCUI 784649

Orange Book

A206098

ABABAB

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": "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": "46708-199_b8b5c58b-40db-4b6f-b53d-f11a842bcf28",
  "productndc": "46708-199",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206098",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 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 2.5MG BASE",
        "product_no": "003",
        "approval_date": "Jul 19, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ASENAPINE",
  "proprietary_name": "Asenapine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206098",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Asenapine",
  "start_marketing_date": "20201210",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N05AH05.

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