Felbatol

Orange BookUNIISPLATC N03AX10

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

Identification

ManufacturerViatris Specialty LLC

CountryUS (United States)

ATC codeN03AX10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0037043101
100 TABLET in 1 BOTTLE, PLASTIC (0037-0431-01)

Annotations

UNII (FDA Substance ID)

X72RBB02N8

FELBAMATE

RxCUI 24812

Orange Book

N020189

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "X72RBB02N8",
    "rxcui": "24812",
    "inchikey": "WKGXYQFOCVYPAC-UHFFFAOYSA-N",
    "display_name": "FELBAMATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2f522701-397a-11de-8a39-0800200c9a66": {
      "match": "brand_token",
      "title": "FELBATOL (FELBAMATE) TABLET FELBATOL (FELBAMATE) SUSPENSION [VIATRIS SPECIALTY LLC]",
      "spl_version": "16",
      "published_date": "2025-12-31"
    }
  },
  "productid": "0037-0431_374f8c69-4219-47fd-aeda-8edc73da5411",
  "productndc": "0037-0431",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "020189",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Jul 29, 1993"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "Jul 29, 1993"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "600MG/5ML",
        "product_no": "003",
        "approval_date": "Jul 29, 1993"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FELBAMATE",
  "proprietary_name": "Felbatol",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020189",
  "marketing_category": "NDA",
  "nonproprietary_name": "felbamate",
  "start_marketing_date": "19930729",
  "active_numerator_strength": "600"
}

Related drugs

Other records sharing ATC code N03AX10.

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