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United States · US · US:65162-735_28bca98d-c89a-492a-a3e5-405098e33919

Felbamate

Orange BookUNIISPLATC N03AX10

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

Identification

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

Packs · 5

  • ndc11
    6516273503
    30 TABLET in 1 BOTTLE (65162-735-03)
  • ndc11
    6516273509
    90 TABLET in 1 BOTTLE (65162-735-09)
  • ndc11
    6516273518
    180 TABLET in 1 BOTTLE (65162-735-18)
  • ndc11
    6516273527
    270 TABLET in 1 BOTTLE (65162-735-27)
  • ndc11
    6516273550
    500 TABLET in 1 BOTTLE (65162-735-50)

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": "65162-735_28bca98d-c89a-492a-a3e5-405098e33919",
  "productndc": "65162-735",
  "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": "20110916",
  "active_numerator_strength": "600"
}

Related drugs

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