Aptiom

Orange BookSPL

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

Identification

ManufacturerSumitomo Pharma America, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6340224856
4 BLISTER PACK in 1 CARTON (63402-248-56) / 1 KIT in 1 BLISTER PACK (63402-248-14) * 7 TABLET in 1 BLISTER PACK (63402-204-17) * 7 TABLET in 1 BLISTER PACK (63402-208-17)

Annotations

Orange Book

N022416

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "ORAL",
  "spl_meta": {
    "3d0c9554-eaeb-4694-8089-00133fcadce3": {
      "match": "brand_token",
      "title": "APTIOM (ESLICARBAZEPINE ACETATE) TABLET APTIOM (ESLICARBAZEPINE ACETATE) KIT [SUMITOMO PHARMA AMERICA, INC.]",
      "spl_version": "16",
      "published_date": "2023-12-05"
    }
  },
  "productid": "63402-248_3af99c5d-50e2-4336-8a5e-e93b6cf3618a",
  "productndc": "63402-248",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "022416",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Nov 8, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "002",
        "approval_date": "Nov 8, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "003",
        "approval_date": "Nov 8, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "004",
        "approval_date": "Nov 8, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Aptiom",
  "active_ingred_unit": null,
  "application_number": "NDA022416",
  "marketing_category": "NDA",
  "nonproprietary_name": "ESLICARBAZEPINE ACETATE",
  "start_marketing_date": "20140407",
  "active_numerator_strength": null
}

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