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
7133597270
28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-0)
ndc11
7133597271
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-1)
ndc11
7133597272
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-2)
ndc11
7133597273
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-3)
ndc11
7133597274
56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-4)
ndc11
7133597275
84 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-5)
ndc11
7133597276
120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-6)
ndc11
7133597277
7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-7)
ndc11
7133597278
14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-8)
ndc11
7133597279
45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-9)

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": "71335-9727_e00d0107-e233-4b4c-a837-9a2d0123c8b4",
  "productndc": "71335-9727",
  "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": "25"
}

Related drugs

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