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United States · US · US:51862-376_cf0e1842-298b-47e7-9d51-f0789ae086ca

SORILUX

Orange BookUNIISPLATC D05AX02

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

Identification

ManufacturerMayne Pharma
CountryUS (United States)
ATC codeD05AX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5186237612
    1 CAN in 1 CARTON (51862-376-12) / 120 g in 1 CAN

Annotations

UNII (FDA Substance ID)
143NQ3779B
CALCIPOTRIENE
RxCUI 29365
Orange Book
N022563
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "143NQ3779B",
    "rxcui": "29365",
    "inchikey": "LWQQLNNNIPYSNX-UROSTWAQSA-N",
    "display_name": "CALCIPOTRIENE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "51f208d0-7b3f-44cc-8bed-92fa3d2e7bbe": {
      "match": "brand_token",
      "title": "SORILUX (CALCIPOTRIENE) AEROSOL, FOAM [MAYNE PHARMA]",
      "spl_version": "7",
      "published_date": "2024-05-13"
    }
  },
  "productid": "51862-376_cf0e1842-298b-47e7-9d51-f0789ae086ca",
  "productndc": "51862-376",
  "dosage_form": "AEROSOL, FOAM",
  "orange_book": {
    "appl_no": "022563",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.005%",
        "product_no": "001",
        "approval_date": "Oct 6, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CALCIPOTRIENE",
  "proprietary_name": "SORILUX",
  "active_ingred_unit": "ug/g",
  "application_number": "NDA022563",
  "marketing_category": "NDA",
  "nonproprietary_name": "calcipotriene",
  "start_marketing_date": "20170411",
  "active_numerator_strength": "50"
}

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