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United States · US · US:42385-945_f0e00f9f-65f5-407a-e053-2a95a90a260f

FENOFIBRIC ACID DELAYED-RELEASE

Orange BookUNIISPLATC C10AB

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

Identification

ManufacturerLaurus Labs Limited
CountryUS (United States)
ATC codeC10AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4238594511
    1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-945-11)
  • ndc11
    4238594530
    30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-945-30)
  • ndc11
    4238594590
    90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-945-90)

Annotations

UNII (FDA Substance ID)
BGF9MN2HU1
FENOFIBRIC ACID
RxCUI 24852
Orange Book
A211626
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "BGF9MN2HU1",
    "rxcui": "24852",
    "inchikey": "MQOBSOSZFYZQOK-UHFFFAOYSA-N",
    "display_name": "FENOFIBRIC ACID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "369b3e55-2c05-d879-fe7e-91296c529ae9": {
      "match": "brand_token",
      "title": "FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]",
      "spl_version": "89",
      "published_date": "2025-11-19"
    }
  },
  "productid": "42385-945_f0e00f9f-65f5-407a-e053-2a95a90a260f",
  "productndc": "42385-945",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "211626",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 45MG FENOFIBRIC ACID",
        "product_no": "001",
        "approval_date": "Jul 18, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 135MG FENOFIBRIC ACID",
        "product_no": "002",
        "approval_date": "Jul 18, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FENOFIBRIC ACID",
  "proprietary_name": "FENOFIBRIC ACID DELAYED-RELEASE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211626",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fenofibric Acid",
  "start_marketing_date": "20200824",
  "active_numerator_strength": "135"
}

Related drugs

Other records sharing ATC code C10AB.

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