Topiramate

Orange BookUNIISPLATC N03AX11

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeN03AX11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
4733571008
100 TABLET, FILM COATED in 1 BOTTLE (47335-710-08)
ndc11
4733571013
500 TABLET, FILM COATED in 1 BOTTLE (47335-710-13)
ndc11
4733571018
1000 TABLET, FILM COATED in 1 BOTTLE (47335-710-18)
ndc11
4733571083
30 TABLET, FILM COATED in 1 BOTTLE (47335-710-83)
ndc11
4733571086
60 TABLET, FILM COATED in 1 BOTTLE (47335-710-86)
ndc11
4733571088
100 TABLET, FILM COATED in 1 BOTTLE (47335-710-88)

Annotations

UNII (FDA Substance ID)

0H73WJJ391

TOPIRAMATE

RxCUI 38404

Orange Book

A090278

ABABAB

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": "47335-710_532f72d6-a509-0681-e063-6294a90ad4c1",
  "productndc": "47335-710",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090278",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Mar 27, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Mar 27, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Mar 27, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Mar 27, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOPIRAMATE",
  "proprietary_name": "Topiramate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090278",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Topiramate",
  "start_marketing_date": "20141215",
  "active_numerator_strength": "50"
}

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