topiramate

Orange BookUNIISPLATC N03AX11

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN03AX11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7133510640
20 TABLET, FILM COATED in 1 BOTTLE (71335-1064-0)
ndc11
7133510641
30 TABLET, FILM COATED in 1 BOTTLE (71335-1064-1)
ndc11
7133510642
60 TABLET, FILM COATED in 1 BOTTLE (71335-1064-2)
ndc11
7133510643
90 TABLET, FILM COATED in 1 BOTTLE (71335-1064-3)
ndc11
7133510644
120 TABLET, FILM COATED in 1 BOTTLE (71335-1064-4)
ndc11
7133510645
7 TABLET, FILM COATED in 1 BOTTLE (71335-1064-5)
ndc11
7133510646
80 TABLET, FILM COATED in 1 BOTTLE (71335-1064-6)
ndc11
7133510647
14 TABLET, FILM COATED in 1 BOTTLE (71335-1064-7)
ndc11
7133510648
45 TABLET, FILM COATED in 1 BOTTLE (71335-1064-8)
ndc11
7133510649
28 TABLET, FILM COATED in 1 BOTTLE (71335-1064-9)

Annotations

UNII (FDA Substance ID)

0H73WJJ391

TOPIRAMATE

RxCUI 38404

Orange Book

A090162

ABABABAB

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": "71335-1064_32edb528-3bc4-b4e0-e063-6294a90afd5b",
  "productndc": "71335-1064",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090162",
    "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": "AB",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Feb 19, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOPIRAMATE",
  "proprietary_name": "topiramate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090162",
  "marketing_category": "ANDA",
  "nonproprietary_name": "topiramate",
  "start_marketing_date": "20130701",
  "active_numerator_strength": "50"
}

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