Felbamate

Orange BookUNIISPLATC N03AX10

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

Identification

ManufacturerViona Pharmaceuticals Inc

CountryUS (United States)

ATC codeN03AX10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7257805701
100 TABLET in 1 BOTTLE (72578-057-01)
ndc11
7257805705
500 TABLET in 1 BOTTLE (72578-057-05)
ndc11
7257805706
30 TABLET in 1 BOTTLE (72578-057-06)
ndc11
7257805716
90 TABLET in 1 BOTTLE (72578-057-16)
ndc11
7257805728
180 TABLET in 1 BOTTLE (72578-057-28)
ndc11
7257805777
10 BLISTER PACK in 1 CARTON (72578-057-77) / 10 TABLET in 1 BLISTER PACK (72578-057-30)

Annotations

UNII (FDA Substance ID)

X72RBB02N8

FELBAMATE

RxCUI 24812

Orange Book

A208970

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": {
    "696e3cbb-a431-4f29-acbd-1db8e9aaef93": {
      "match": "brand_token",
      "title": "FELBAMATE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "102",
      "published_date": "2026-03-30"
    }
  },
  "productid": "72578-057_e719dd84-3938-4531-871c-4433fec8f4a6",
  "productndc": "72578-057",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208970",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "May 30, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "May 30, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FELBAMATE",
  "proprietary_name": "Felbamate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208970",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Felbamate",
  "start_marketing_date": "20200303",
  "active_numerator_strength": "600"
}

Related drugs

Other records sharing ATC code N03AX10.

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