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United States · US · US:67386-314_68dbe31c-2dbe-49ad-8b2e-2cf1b8521167

Onfi

Orange BookUNIISPLATC N05BA09

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

Identification

ManufacturerLundbeck Pharmaceuticals LLC
CountryUS (United States)
ATC codeN05BA09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6738631401
    1 BOTTLE in 1 CARTON (67386-314-01) / 100 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
2MRO291B4U
CLOBAZAM
RxCUI 21241
Orange Book
N202067
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2MRO291B4U",
    "rxcui": "21241",
    "inchikey": "CXOXHMZGEKVPMT-UHFFFAOYSA-N",
    "display_name": "CLOBAZAM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "de03bd69-2dca-459c-93b4-541fd3e9571c": {
      "match": "brand_token",
      "title": "ONFI (CLOBAZAM) TABLET ONFI (CLOBAZAM) SUSPENSION [LUNDBECK PHARMACEUTICALS LLC]",
      "spl_version": "42",
      "published_date": "2025-12-17"
    }
  },
  "productid": "67386-314_68dbe31c-2dbe-49ad-8b2e-2cf1b8521167",
  "productndc": "67386-314",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202067",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Oct 21, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Oct 21, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Oct 21, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOBAZAM",
  "proprietary_name": "Onfi",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA202067",
  "marketing_category": "NDA",
  "nonproprietary_name": "clobazam",
  "start_marketing_date": "20131210",
  "active_numerator_strength": "10"
}

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