Topiramate

Orange BookUNIISPLATC N03AX11

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

Identification

ManufacturerZydus Lifesciences Limited

CountryUS (United States)

ATC codeN03AX11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
7077113171
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1317-1)
ndc11
7077113173
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1317-3)
ndc11
7077113174
10 BLISTER PACK in 1 CARTON (70771-1317-4) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70771-1317-2)
ndc11
7077113175
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1317-5)
ndc11
7077113179
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1317-9)

Annotations

UNII (FDA Substance ID)

0H73WJJ391

TOPIRAMATE

RxCUI 38404

Orange Book

A207382

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": "70771-1317_709dd70b-24e1-435f-8373-02e6dd538b2c",
  "productndc": "70771-1317",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "207382",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Nov 24, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Nov 24, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Nov 24, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Oct 30, 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": "ANDA207382",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Topiramate",
  "start_marketing_date": "20180405",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N03AX11.

Access this data programmatically

Query Topiramate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs