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United States · US · US:68094-123_43ea970d-701d-409d-b9a1-4e0c171ede4d

Oxcarbazepine

Orange BookUNIISPLATC N03AF02

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

Identification

ManufacturerPrecision Dose, Inc.
CountryUS (United States)
ATC codeN03AF02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6809412362
    3 TRAY in 1 CASE (68094-123-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-123-59)

Annotations

UNII (FDA Substance ID)
VZI5B1W380
OXCARBAZEPINE
RxCUI 32624
Orange Book
A202961
AB
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": "68094-123_43ea970d-701d-409d-b9a1-4e0c171ede4d",
  "productndc": "68094-123",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "202961",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG/5ML",
        "product_no": "001",
        "approval_date": "Sep 17, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXCARBAZEPINE",
  "proprietary_name": "Oxcarbazepine",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA202961",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxcarbazepine",
  "start_marketing_date": "20170913",
  "active_numerator_strength": "300"
}

Related drugs

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