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United States · US · US:71335-0090_acf0fa26-5b16-424b-9e49-91ee29c7e5fd

OXCARBAZEPINE

Orange BookUNIISPLATC N03AF02

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN03AF02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    7133500901
    30 TABLET, FILM COATED in 1 BOTTLE (71335-0090-1)
  • ndc11
    7133500902
    60 TABLET, FILM COATED in 1 BOTTLE (71335-0090-2)
  • ndc11
    7133500903
    90 TABLET, FILM COATED in 1 BOTTLE (71335-0090-3)
  • ndc11
    7133500904
    180 TABLET, FILM COATED in 1 BOTTLE (71335-0090-4)
  • ndc11
    7133500905
    120 TABLET, FILM COATED in 1 BOTTLE (71335-0090-5)

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": "71335-0090_acf0fa26-5b16-424b-9e49-91ee29c7e5fd",
  "productndc": "71335-0090",
  "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": "20080111",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code N03AF02.

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