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United States · US · US:27437-108_7ca6a804-2dff-43b3-848e-7a58b31fb268

Antara

Orange BookUNIISPLATC C10AB05

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC10AB05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
N021695
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": {
    "24790a18-0291-4b88-a724-acac43b616ce": {
      "match": "brand_token",
      "title": "ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMACEUTICALS, INC.]",
      "spl_version": "17",
      "published_date": "2025-11-24"
    }
  },
  "productid": "27437-108_7ca6a804-2dff-43b3-848e-7a58b31fb268",
  "productndc": "27437-108",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "021695",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "43MG",
        "product_no": "001",
        "approval_date": "Nov 30, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "87MG",
        "product_no": "002",
        "approval_date": "Nov 30, 2004"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "130MG",
        "product_no": "003",
        "approval_date": "Nov 30, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Oct 18, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "005",
        "approval_date": "Oct 18, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FENOFIBRATE",
  "proprietary_name": "Antara",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021695",
  "marketing_category": "NDA",
  "nonproprietary_name": "fenofibrate",
  "start_marketing_date": "20131101",
  "active_numerator_strength": "90"
}

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