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United States · US · US:69238-2088_e90bb84a-0b45-4163-92da-d8ed239a0b1d

Bexarotene

Orange BookUNIISPLATC L01XF03

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeL01XF03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6923820886
    1 TUBE in 1 CARTON (69238-2088-6) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
A61RXM4375
BEXAROTENE
RxCUI 233272
Orange Book
A215398
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": "TOPICAL",
  "spl_meta": {
    "f9514265-6e2c-9030-e053-6394a90aa04b": {
      "match": "brand_token",
      "title": "BEXAROTENE CAPSULE [AVKARE]",
      "spl_version": "2",
      "published_date": "2025-11-17"
    }
  },
  "productid": "69238-2088_e90bb84a-0b45-4163-92da-d8ed239a0b1d",
  "productndc": "69238-2088",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "215398",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Apr 27, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BEXAROTENE",
  "proprietary_name": "Bexarotene",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA215398",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bexarotene",
  "start_marketing_date": "20220504",
  "active_numerator_strength": "10"
}

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