TOPIRAMATE

Orange BookUNIISPLATC N03AX11

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC codeN03AX11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6846237405
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-374-05)
ndc11
6846237430
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-374-30)
ndc11
6846237490
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-374-90)

Annotations

UNII (FDA Substance ID)

0H73WJJ391

TOPIRAMATE

RxCUI 38404

Orange Book

A210278

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": "68462-374_4a2276a1-54f6-4de6-8710-c2c088a23e76",
  "productndc": "68462-374",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "210278",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Feb 1, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Feb 1, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Feb 1, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "150MG",
        "product_no": "004",
        "approval_date": "Feb 1, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "200MG",
        "product_no": "005",
        "approval_date": "Feb 1, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOPIRAMATE",
  "proprietary_name": "TOPIRAMATE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210278",
  "marketing_category": "ANDA",
  "nonproprietary_name": "topiramate",
  "start_marketing_date": "20210201",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N03AX11.

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