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United States · US · US:17772-103_4d7bcc14-c816-0b67-e063-6394a90a1097

Trokendi XR

Orange BookUNIISPLATC N03AX11

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

Identification

ManufacturerSupernus Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN03AX11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    1777210301
    100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-01)
  • ndc11
    1777210307
    7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-07)
  • ndc11
    1777210310
    5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-103-10)
  • ndc11
    1777210312
    7 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-103-12)
  • ndc11
    1777210330
    30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-30)

Annotations

UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
N201635
AB1AB1AB1AB1
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0H73WJJ391",
    "rxcui": "38404",
    "inchikey": "KJADKKWYZYXHBB-XBWDGYHZSA-N",
    "display_name": "TOPIRAMATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2dc7957e-a3e5-46bb-aa66-f3250f872f5e": {
      "match": "brand_token",
      "title": "TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]",
      "spl_version": "29",
      "published_date": "2026-03-23"
    }
  },
  "productid": "17772-103_4d7bcc14-c816-0b67-e063-6394a90a1097",
  "productndc": "17772-103",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "201635",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Aug 16, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Aug 16, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Aug 16, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB1",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Aug 16, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOPIRAMATE",
  "proprietary_name": "Trokendi XR",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA201635",
  "marketing_category": "NDA",
  "nonproprietary_name": "topiramate",
  "start_marketing_date": "20130816",
  "active_numerator_strength": "100"
}

Related drugs

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