Eslicarbazepine Acetate

Orange BookUNIISPLATC N03AF04

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

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeN03AF04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6787758760
60 TABLET in 1 BOTTLE (67877-587-60)

Annotations

UNII (FDA Substance ID)

BEA68ZVB2K

ESLICARBAZEPINE ACETATE

RxCUI 1482501

Orange Book

A211199

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "BEA68ZVB2K",
    "rxcui": "1482501",
    "inchikey": "QIALRBLEEWJACW-INIZCTEOSA-N",
    "display_name": "ESLICARBAZEPINE ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d279e461-2611-4f5c-938d-5d117612894f": {
      "match": "brand_token",
      "title": "ESLICARBAZEPINE ACETATE TABLET [TORRENT PHARMACEUTICALS LIMITED]",
      "spl_version": "6",
      "published_date": "2025-08-01"
    }
  },
  "productid": "67877-587_ca4bcb9f-157d-4d49-92f5-6b76745aabe1",
  "productndc": "67877-587",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211199",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Oct 6, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "002",
        "approval_date": "Oct 6, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "003",
        "approval_date": "Oct 6, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "004",
        "approval_date": "Oct 6, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESLICARBAZEPINE ACETATE",
  "proprietary_name": "Eslicarbazepine Acetate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211199",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Eslicarbazepine Acetate",
  "start_marketing_date": "20250506",
  "active_numerator_strength": "600"
}

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