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United States · US · US:82804-209_433d9d03-a36e-42c6-8e4d-f333ed60e45a

Oxcarbazepine

Orange BookUNIISPLATC N03AF02

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN03AF02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8280420972
    120 TABLET, FILM COATED in 1 BOTTLE (82804-209-72)

Annotations

UNII (FDA Substance ID)
VZI5B1W380
OXCARBAZEPINE
RxCUI 32624
Orange Book
A215939
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": "82804-209_433d9d03-a36e-42c6-8e4d-f333ed60e45a",
  "productndc": "82804-209",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215939",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Jan 11, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Jan 11, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "003",
        "approval_date": "Jan 11, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXCARBAZEPINE",
  "proprietary_name": "Oxcarbazepine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215939",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxcarbazepine",
  "start_marketing_date": "20220111",
  "active_numerator_strength": "300"
}

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