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United States · US · US:73499-001_22617d3b-9736-472b-bc08-1ce53fe151aa

Wynzora

Orange BookUNIISPLATC A07EA

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

Identification

ManufacturerMC2 Therapeutics Ltd
CountryUS (United States)
ATC codeA07EA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7349900101
    1 TUBE in 1 CARTON (73499-001-01) / 60 g in 1 TUBE
  • ndc11
    7349900103
    10 TUBE in 1 CARTON (73499-001-03) / 5 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
826Y60901U
BETAMETHASONE DIPROPIONATE
RxCUI 19254
Orange Book
N213422
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "826Y60901U",
    "rxcui": "19254",
    "inchikey": "CIWBQSYVNNPZIQ-XYWKZLDCSA-N",
    "display_name": "BETAMETHASONE DIPROPIONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "36c5c818-0d40-445e-a3c0-0f46723a25e2": {
      "match": "brand_token",
      "title": "WYNZORA (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) CREAM [MC2 THERAPEUTICS LTD]",
      "spl_version": "6",
      "published_date": "2023-12-07"
    }
  },
  "productid": "73499-001_22617d3b-9736-472b-bc08-1ce53fe151aa",
  "productndc": "73499-001",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "213422",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.064%;0.005%",
        "product_no": "001",
        "approval_date": "Jul 20, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE",
  "proprietary_name": "Wynzora",
  "active_ingred_unit": "mg/g; ug/g",
  "application_number": "NDA213422",
  "marketing_category": "NDA",
  "nonproprietary_name": "Calcipotriene and Betamethasone dipropionate",
  "start_marketing_date": "20210630",
  "active_numerator_strength": "64; 50"
}

Related drugs

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