Back to search
🇺🇸

United States · US · US:71335-1286_a172b051-67cc-4410-b405-ed484c43c073

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
    7133512861
    30 TABLET in 1 BOTTLE (71335-1286-1)
  • ndc11
    7133512862
    90 TABLET in 1 BOTTLE (71335-1286-2)
  • ndc11
    7133512863
    60 TABLET in 1 BOTTLE (71335-1286-3)
  • ndc11
    7133512864
    28 TABLET in 1 BOTTLE (71335-1286-4)
  • ndc11
    7133512865
    100 TABLET in 1 BOTTLE (71335-1286-5)

Annotations

UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A210138
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": "71335-1286_a172b051-67cc-4410-b405-ed484c43c073",
  "productndc": "71335-1286",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210138",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "54MG",
        "product_no": "001",
        "approval_date": "Jul 23, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "160MG",
        "product_no": "002",
        "approval_date": "Jul 23, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FENOFIBRATE",
  "proprietary_name": "fenofibrate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210138",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fenofibrate",
  "start_marketing_date": "20180720",
  "active_numerator_strength": "160"
}

Related drugs

Other records sharing ATC code C10AB05.

Access this data programmatically

Query fenofibrate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.