Topamax

Orange BookUNIISPLATC N03AX11

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

Identification

ManufacturerJanssen Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN03AX11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5045864065
60 TABLET, COATED in 1 BOTTLE (50458-640-65)

Annotations

UNII (FDA Substance ID)

0H73WJJ391

TOPIRAMATE

RxCUI 38404

Orange Book

N020505

ABABABAB

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": {
    "21628112-0c47-11df-95b3-498d55d89593": {
      "match": "brand_token",
      "title": "TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]",
      "spl_version": "30",
      "published_date": "2026-03-16"
    }
  },
  "productid": "50458-640_1c7483cf-95db-4b1c-ae4c-b11bc95a6ad8",
  "productndc": "50458-640",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "020505",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Dec 24, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Dec 24, 1996"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Dec 24, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "004",
        "approval_date": "Dec 24, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "005",
        "approval_date": "Dec 24, 1996"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "400MG",
        "product_no": "006",
        "approval_date": "Dec 24, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOPIRAMATE",
  "proprietary_name": "Topamax",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020505",
  "marketing_category": "NDA",
  "nonproprietary_name": "topiramate",
  "start_marketing_date": "19970101",
  "active_numerator_strength": "50"
}

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