Topiramate

Orange BookUNIISPLATC N03AX11

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

Identification

ManufacturerVitruvias Therapeutics, Inc.

CountryUS (United States)

ATC codeN03AX11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6968017930
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-179-30)

Annotations

UNII (FDA Substance ID)

0H73WJJ391

TOPIRAMATE

RxCUI 38404

Orange Book

A215638

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": {
    "4e914420-a65b-98ba-e063-6394a90a14c4": {
      "match": "brand_token",
      "title": "TOPIRAMATE SOLUTION [KESIN PHARMA]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "69680-179_0a7f1a1b-961e-4458-8312-7920a78e4dbe",
  "productndc": "69680-179",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "215638",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Nov 5, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Nov 5, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Nov 5, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "150MG",
        "product_no": "004",
        "approval_date": "Nov 5, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "200MG",
        "product_no": "005",
        "approval_date": "Nov 5, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOPIRAMATE",
  "proprietary_name": "Topiramate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215638",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Topiramate",
  "start_marketing_date": "20250407",
  "active_numerator_strength": "100"
}

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