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United States · US · US:51862-295_4c23641b-0092-4d63-e063-6394a90aa62e

FABIOR

Orange BookUNIISPLATC D05AX05

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

Identification

ManufacturerMayne Pharma
CountryUS (United States)
ATC codeD05AX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5186229510
    1 CAN in 1 CARTON (51862-295-10) / 100 g in 1 CAN

Annotations

UNII (FDA Substance ID)
81BDR9Y8PS
TAZAROTENE
RxCUI 83947
Orange Book
N202428
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "81BDR9Y8PS",
    "rxcui": "83947",
    "inchikey": "OGQICQVSFDPSEI-UHFFFAOYSA-N",
    "display_name": "TAZAROTENE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "ae0afed7-1d60-45fd-a08b-8db094618521": {
      "match": "brand_token",
      "title": "FABIOR (TAZAROTENE) AEROSOL, FOAM [MAYNE PHARMA]",
      "spl_version": "7",
      "published_date": "2026-03-05"
    }
  },
  "productid": "51862-295_4c23641b-0092-4d63-e063-6394a90aa62e",
  "productndc": "51862-295",
  "dosage_form": "AEROSOL, FOAM",
  "orange_book": {
    "appl_no": "202428",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "May 11, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TAZAROTENE",
  "proprietary_name": "FABIOR",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA202428",
  "marketing_category": "NDA",
  "nonproprietary_name": "tazarotene",
  "start_marketing_date": "20170310",
  "active_numerator_strength": "1"
}

Related drugs

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