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United States · US · US:71335-1756_e4d10350-019b-430a-a9c7-0719b1bc65b6

FENOFIBRATE

Orange BookUNIISPLATC C10AB05

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC10AB05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    7133517561
    30 TABLET in 1 BOTTLE (71335-1756-1)
  • ndc11
    7133517562
    90 TABLET in 1 BOTTLE (71335-1756-2)
  • ndc11
    7133517563
    60 TABLET in 1 BOTTLE (71335-1756-3)
  • ndc11
    7133517564
    28 TABLET in 1 BOTTLE (71335-1756-4)
  • ndc11
    7133517565
    100 TABLET in 1 BOTTLE (71335-1756-5)

Annotations

UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A213864
ABAB
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": "71335-1756_e4d10350-019b-430a-a9c7-0719b1bc65b6",
  "productndc": "71335-1756",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213864",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "54MG",
        "product_no": "001",
        "approval_date": "Jun 12, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "160MG",
        "product_no": "002",
        "approval_date": "Jun 12, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FENOFIBRATE",
  "proprietary_name": "FENOFIBRATE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213864",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FENOFIBRATE",
  "start_marketing_date": "20200910",
  "active_numerator_strength": "160"
}

Related drugs

Other records sharing ATC code C10AB05.

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