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United States · US · US:42858-200_ed6ef266-83c1-4183-83a0-a10b76a55e49

Fenofibrate

Orange BookUNIISPLATC C10AB05

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

Identification

ManufacturerRhodes Pharmaceuticals LLC
CountryUS (United States)
ATC codeC10AB05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4285820001
    100 CAPSULE in 1 BOTTLE (42858-200-01)

Annotations

UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A075753
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "U202363UOS",
    "rxcui": "221100",
    "inchikey": "YMTINGFKWWXKFG-UHFFFAOYSA-N",
    "display_name": "FENOFIBRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3a69e15a-eda6-4a6e-8934-6881e4370521": {
      "match": "brand_token",
      "title": "FENOFIBRATE CAPSULE [ANI PHARMACEUTICALS, INC.]",
      "spl_version": "10",
      "published_date": "2026-06-01"
    }
  },
  "productid": "42858-200_ed6ef266-83c1-4183-83a0-a10b76a55e49",
  "productndc": "42858-200",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "075753",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "67MG",
        "product_no": "001",
        "approval_date": "Sep 3, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "134MG",
        "product_no": "002",
        "approval_date": "Apr 9, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Apr 9, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FENOFIBRATE",
  "proprietary_name": "Fenofibrate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075753",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fenofibrate",
  "start_marketing_date": "20170601",
  "active_numerator_strength": "200"
}

Related drugs

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