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United States · US · US:17772-121_41c1a4d4-ff5a-00b4-e063-6294a90a6ec7

OXTELLAR XR

Orange BookUNIISPLATC N03AF02

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

Identification

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

Packs · 3

  • ndc11
    1777212101
    100 TABLET in 1 BOTTLE (17772-121-01)
  • ndc11
    1777212107
    7 TABLET in 1 BOTTLE (17772-121-07)
  • ndc11
    1777212110
    5 TABLET in 1 BLISTER PACK (17772-121-10)

Annotations

UNII (FDA Substance ID)
VZI5B1W380
OXCARBAZEPINE
RxCUI 32624
Orange Book
N202810
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": {
    "aa610e56-1d1d-11e1-8bc2-0800200c9a66": {
      "match": "brand_token",
      "title": "OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS PHARMACEUTICALS, INC.]",
      "spl_version": "21",
      "published_date": "2025-11-17"
    }
  },
  "productid": "17772-121_41c1a4d4-ff5a-00b4-e063-6294a90a6ec7",
  "productndc": "17772-121",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202810",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Oct 19, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Oct 19, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "003",
        "approval_date": "Oct 19, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXCARBAZEPINE",
  "proprietary_name": "OXTELLAR XR",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA202810",
  "marketing_category": "NDA",
  "nonproprietary_name": "OXCARBAZEPINE",
  "start_marketing_date": "20130117",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code N03AF02.

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