QUDEXY

Orange BookUNIISPLATC N03AX11

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerUpsher-Smith Laboratories, LLC

CountryUS (United States)

ATC codeN03AX11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0245107330
1 BOTTLE in 1 CARTON (0245-1073-30) / 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
ndc11
0245107390
1 BOTTLE in 1 CARTON (0245-1073-90) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

0H73WJJ391

TOPIRAMATE

RxCUI 38404

Orange Book

N205122

AB2AB2AB2AB2AB2

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": {
    "46f54677-3a22-4c38-9b92-923020164e15": {
      "match": "brand_token",
      "title": "QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC]",
      "spl_version": "29",
      "published_date": "2026-04-02"
    }
  },
  "productid": "0245-1073_c282e476-f752-48da-ae0f-2987d682a4b8",
  "productndc": "0245-1073",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "205122",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Mar 11, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Mar 11, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Mar 11, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "150MG",
        "product_no": "004",
        "approval_date": "Mar 11, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB2",
        "strength": "200MG",
        "product_no": "005",
        "approval_date": "Mar 11, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOPIRAMATE",
  "proprietary_name": "QUDEXY",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA205122",
  "marketing_category": "NDA",
  "nonproprietary_name": "Topiramate",
  "start_marketing_date": "20140411",
  "active_numerator_strength": "200"
}

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