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
6275671208
100 TABLET, FILM COATED in 1 BOTTLE (62756-712-08)
ndc11
6275671213
500 TABLET, FILM COATED in 1 BOTTLE (62756-712-13)
ndc11
6275671218
1000 TABLET, FILM COATED in 1 BOTTLE (62756-712-18)
ndc11
6275671283
30 TABLET, FILM COATED in 1 BOTTLE (62756-712-83)
ndc11
6275671286
60 TABLET, FILM COATED in 1 BOTTLE (62756-712-86)
ndc11
6275671288
100 TABLET, FILM COATED in 1 BOTTLE (62756-712-88)

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": "62756-712_b8c52970-05b0-43ea-9122-566998bf4524",
  "productndc": "62756-712",
  "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": "20090327",
  "active_numerator_strength": "200"
}

Related drugs

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