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United States · US · US:53746-734_b9ac064d-eed2-4d3c-b984-c9ebcef68646

Felbamate

Orange BookUNIISPLATC N03AX10

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeN03AX10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5374673430
    30 TABLET in 1 BOTTLE (53746-734-30)
  • ndc11
    5374673490
    90 TABLET in 1 BOTTLE (53746-734-90)

Annotations

UNII (FDA Substance ID)
X72RBB02N8
FELBAMATE
RxCUI 24812
Orange Book
A201680
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": "53746-734_b9ac064d-eed2-4d3c-b984-c9ebcef68646",
  "productndc": "53746-734",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "201680",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Sep 13, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "Sep 13, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FELBAMATE",
  "proprietary_name": "Felbamate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA201680",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Felbamate",
  "start_marketing_date": "20220810",
  "active_numerator_strength": "400"
}

Related drugs

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