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United States · US · US:60505-4660_34bede3a-5e85-4291-a95a-3e4d752e89f9

Eslicarbazepine Acetate

Orange BookUNIISPLATC N03AF04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerApotex Corp.
CountryUS (United States)
ATC codeN03AF04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6050546606
    60 TABLET in 1 BOTTLE (60505-4660-6)
  • ndc11
    6050546609
    90 TABLET in 1 BOTTLE (60505-4660-9)

Annotations

UNII (FDA Substance ID)
BEA68ZVB2K
ESLICARBAZEPINE ACETATE
RxCUI 1482501
Orange Book
A211236
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": "60505-4660_34bede3a-5e85-4291-a95a-3e4d752e89f9",
  "productndc": "60505-4660",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211236",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Dec 7, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "002",
        "approval_date": "Dec 7, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "003",
        "approval_date": "Dec 7, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "004",
        "approval_date": "Dec 7, 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": "ANDA211236",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Eslicarbazepine Acetate",
  "start_marketing_date": "20250506",
  "active_numerator_strength": "600"
}

Related drugs

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