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United States · US · US:43975-315_07544503-a705-48cb-9a86-5bb5ece3fb91

Bexarotene

Orange BookUNIISPLATC L01XF03

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

Identification

ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01XF03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4397531510
    100 CAPSULE, LIQUID FILLED in 1 BOTTLE (43975-315-10)

Annotations

UNII (FDA Substance ID)
A61RXM4375
BEXAROTENE
RxCUI 233272
Orange Book
A209861
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "A61RXM4375",
    "rxcui": "233272",
    "inchikey": "NAVMQTYZDKMPEU-UHFFFAOYSA-N",
    "display_name": "BEXAROTENE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f9514265-6e2c-9030-e053-6394a90aa04b": {
      "match": "brand_token",
      "title": "BEXAROTENE CAPSULE [AVKARE]",
      "spl_version": "2",
      "published_date": "2025-11-17"
    }
  },
  "productid": "43975-315_07544503-a705-48cb-9a86-5bb5ece3fb91",
  "productndc": "43975-315",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "209861",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "001",
        "approval_date": "May 8, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BEXAROTENE",
  "proprietary_name": "Bexarotene",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209861",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bexarotene",
  "start_marketing_date": "20180510",
  "active_numerator_strength": "75"
}

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