OXCARBAZEPINE

Orange BookUNIISPLATC N03AF02

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

Identification

ManufacturerMajor Pharmaceuticals

CountryUS (United States)

ATC codeN03AF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0904726261
100 BLISTER PACK in 1 CARTON (0904-7262-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

VZI5B1W380

OXCARBAZEPINE

RxCUI 32624

Orange Book

A078069

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "VZI5B1W380",
    "rxcui": "32624",
    "inchikey": "CTRLABGOLIVAIY-UHFFFAOYSA-N",
    "display_name": "OXCARBAZEPINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a18f591b-587e-4769-8ac2-9cfba0b82526": {
      "match": "brand_token",
      "title": "OXCARBAZEPINE (OXCARBAZEPINE) SUSPENSION [CAMBER PHARMACEUTICALS, INC.]",
      "spl_version": "3",
      "published_date": "2026-05-25"
    }
  },
  "productid": "0904-7262_55b0fa69-7b11-49df-972a-e1d39b35b322",
  "productndc": "0904-7262",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078069",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Jan 11, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Jan 11, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "003",
        "approval_date": "Jan 11, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXCARBAZEPINE",
  "proprietary_name": "OXCARBAZEPINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078069",
  "marketing_category": "ANDA",
  "nonproprietary_name": "OXCARBAZEPINE",
  "start_marketing_date": "20221107",
  "active_numerator_strength": "150"
}

Related drugs

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