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
7133505480
28 TABLET, FILM COATED in 1 BOTTLE (71335-0548-0)
ndc11
7133505481
30 TABLET, FILM COATED in 1 BOTTLE (71335-0548-1)
ndc11
7133505482
60 TABLET, FILM COATED in 1 BOTTLE (71335-0548-2)
ndc11
7133505483
90 TABLET, FILM COATED in 1 BOTTLE (71335-0548-3)
ndc11
7133505484
56 TABLET, FILM COATED in 1 BOTTLE (71335-0548-4)
ndc11
7133505485
84 TABLET, FILM COATED in 1 BOTTLE (71335-0548-5)
ndc11
7133505486
120 TABLET, FILM COATED in 1 BOTTLE (71335-0548-6)
ndc11
7133505487
7 TABLET, FILM COATED in 1 BOTTLE (71335-0548-7)
ndc11
7133505488
14 TABLET, FILM COATED in 1 BOTTLE (71335-0548-8)
ndc11
7133505489
45 TABLET, FILM COATED in 1 BOTTLE (71335-0548-9)

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": "71335-0548_bf69b811-09c7-459c-8e24-e1fa04b9f799",
  "productndc": "71335-0548",
  "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": "20141215",
  "active_numerator_strength": "25"
}

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