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United States · US · US:16714-775_c3010d7b-f928-464e-af7c-ca45a5320a20

Felbamate

Orange BookUNIISPLATC N03AX10

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

Identification

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

Packs · 2

  • ndc11
    1671477501
    237 mL in 1 BOTTLE (16714-775-01)
  • ndc11
    1671477502
    473 mL in 1 BOTTLE (16714-775-02)

Annotations

UNII (FDA Substance ID)
X72RBB02N8
FELBAMATE
RxCUI 24812
Orange Book
A206314
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": "16714-775_c3010d7b-f928-464e-af7c-ca45a5320a20",
  "productndc": "16714-775",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "206314",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG/5ML",
        "product_no": "001",
        "approval_date": "Jun 16, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FELBAMATE",
  "proprietary_name": "Felbamate",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA206314",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Felbamate",
  "start_marketing_date": "20180410",
  "active_numerator_strength": "600"
}

Related drugs

Other records sharing ATC code N03AX10.

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