Eslicarbazepine Acetate

Orange BookUNIISPLATC N03AF04

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

Identification

ManufacturerDr.Reddys Laboratories Inc

CountryUS (United States)

ATC codeN03AF04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4359868530
30 TABLET in 1 BOTTLE (43598-685-30)

Annotations

UNII (FDA Substance ID)

BEA68ZVB2K

ESLICARBAZEPINE ACETATE

RxCUI 1482501

Orange Book

A211238

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": "43598-685_75484338-6d78-877c-086f-61467c8dd5e4",
  "productndc": "43598-685",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211238",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Jun 29, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "002",
        "approval_date": "Jun 29, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "003",
        "approval_date": "Jun 29, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "004",
        "approval_date": "Jun 29, 2021"
      }
    ],
    "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": "ANDA211238",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Eslicarbazepine Acetate",
  "start_marketing_date": "20250506",
  "active_numerator_strength": "400"
}

Related drugs

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