Topiramate

Orange BookUNIISPLATC N03AX11

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

Identification

ManufacturerAvKARE

CountryUS (United States)

ATC codeN03AX11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4229195730
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-957-30)

Annotations

UNII (FDA Substance ID)

0H73WJJ391

TOPIRAMATE

RxCUI 38404

Orange Book

A206210

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": {
    "4e914420-a65b-98ba-e063-6394a90a14c4": {
      "match": "brand_token",
      "title": "TOPIRAMATE SOLUTION [KESIN PHARMA]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "42291-957_48c104bb-d8d9-2940-e063-6394a90aeab3",
  "productndc": "42291-957",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "206210",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Mar 10, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Mar 10, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Mar 10, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Mar 10, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOPIRAMATE",
  "proprietary_name": "Topiramate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206210",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Topiramate",
  "start_marketing_date": "20241030",
  "active_numerator_strength": "100"
}

Related drugs

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