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
7133523181
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2318-1)
ndc11
7133523182
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2318-2)
ndc11
7133523183
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2318-3)
ndc11
7133523184
120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2318-4)
ndc11
7133523185
50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2318-5)
ndc11
7133523186
14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2318-6)
ndc11
7133523187
45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2318-7)
ndc11
7133523188
7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2318-8)

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": "71335-2318_6cafdf58-ef5b-4b0a-98c5-1c06fad0ef99",
  "productndc": "71335-2318",
  "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": "100"
}

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