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United States · US · US:65162-686_5ae2c0c1-5f34-4c23-bb17-169302c2253f

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 · 2

  • ndc11
    6516268688
    237 mL in 1 BOTTLE (65162-686-88)
  • ndc11
    6516268690
    473 mL in 1 BOTTLE (65162-686-90)

Annotations

UNII (FDA Substance ID)
X72RBB02N8
FELBAMATE
RxCUI 24812
Orange Book
A202385
AB
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": "65162-686_5ae2c0c1-5f34-4c23-bb17-169302c2253f",
  "productndc": "65162-686",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "202385",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG/5ML",
        "product_no": "001",
        "approval_date": "Dec 16, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FELBAMATE",
  "proprietary_name": "Felbamate",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA202385",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Felbamate",
  "start_marketing_date": "20111216",
  "active_numerator_strength": "600"
}

Related drugs

Other records sharing ATC code N03AX10.

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