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United States · US · US:70756-214_4a13e20b-6a21-4d45-a159-a2add4ce215e

FENOFIBRATE

Orange BookUNIISPLATC C10AB05

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

Identification

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

Packs · 2

  • ndc11
    7075621451
    500 TABLET in 1 BOTTLE (70756-214-51)
  • ndc11
    7075621490
    90 TABLET in 1 BOTTLE (70756-214-90)

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": "70756-214_4a13e20b-6a21-4d45-a159-a2add4ce215e",
  "productndc": "70756-214",
  "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": "54"
}

Related drugs

Other records sharing ATC code C10AB05.

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