Oxcarbazepine

Orange BookUNIISPLATC N03AF02

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

Identification

ManufacturerIngenus Pharmaceuticals, LLC

CountryUS (United States)

ATC codeN03AF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5074261101
100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-611-01)

Annotations

UNII (FDA Substance ID)

VZI5B1W380

OXCARBAZEPINE

RxCUI 32624

Orange Book

A215796

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": "50742-611_69d2a354-3ced-494f-bda2-f3f5c4635eaa",
  "productndc": "50742-611",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "215796",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Nov 22, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Nov 22, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "003",
        "approval_date": "Nov 22, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXCARBAZEPINE",
  "proprietary_name": "Oxcarbazepine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215796",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxcarbazepine",
  "start_marketing_date": "20250601",
  "active_numerator_strength": "150"
}

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