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 · 8

ndc11
7133511431
60 TABLET, FILM COATED in 1 BOTTLE (71335-1143-1)
ndc11
7133511432
30 TABLET, FILM COATED in 1 BOTTLE (71335-1143-2)
ndc11
7133511433
90 TABLET, FILM COATED in 1 BOTTLE (71335-1143-3)
ndc11
7133511434
120 TABLET, FILM COATED in 1 BOTTLE (71335-1143-4)
ndc11
7133511435
50 TABLET, FILM COATED in 1 BOTTLE (71335-1143-5)
ndc11
7133511436
14 TABLET, FILM COATED in 1 BOTTLE (71335-1143-6)
ndc11
7133511437
45 TABLET, FILM COATED in 1 BOTTLE (71335-1143-7)
ndc11
7133511438
7 TABLET, FILM COATED in 1 BOTTLE (71335-1143-8)

Annotations

UNII (FDA Substance ID)

0H73WJJ391

TOPIRAMATE

RxCUI 38404

Orange Book

A078235

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": "71335-1143_78304e2a-31b5-4b0b-9f72-1842b7735bce",
  "productndc": "71335-1143",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078235",
    "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": "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": "ANDA078235",
  "marketing_category": "ANDA",
  "nonproprietary_name": "topiramate",
  "start_marketing_date": "20090327",
  "active_numerator_strength": "100"
}

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