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United States · US · US:0378-6955_43459ab6-17fd-4c77-b269-4a97780af170

Bexarotene

Orange BookUNIISPLATC L01XF03

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

Identification

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

Packs · 1

  • ndc11
    0378695501
    100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0378-6955-01)

Annotations

UNII (FDA Substance ID)
A61RXM4375
BEXAROTENE
RxCUI 233272
Orange Book
A203174
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": "0378-6955_43459ab6-17fd-4c77-b269-4a97780af170",
  "productndc": "0378-6955",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "203174",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "001",
        "approval_date": "Aug 12, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BEXAROTENE",
  "proprietary_name": "Bexarotene",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203174",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bexarotene",
  "start_marketing_date": "20150709",
  "active_numerator_strength": "75"
}

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