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United States · US · US:85437-008_4d3f3b6d-7f22-1f5c-e063-6294a90a45b3

Halobetasol Propionate

Orange BookUNIISPLATC D07AC21

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

Identification

ManufacturerCoral Way Pharma, LLC
CountryUS (United States)
ATC codeD07AC21
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8543700860
    1 BOTTLE in 1 CARTON (85437-008-60) / 59 g in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
91A0K1TY3Z
HALOBETASOL PROPIONATE
RxCUI 45318
Orange Book
N208183
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "91A0K1TY3Z",
    "rxcui": "45318",
    "inchikey": "BDSYKGHYMJNPAB-LICBFIPMSA-N",
    "display_name": "HALOBETASOL PROPIONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "e408184b-0545-4728-9f95-90d8cdec544a": {
      "match": "brand_token",
      "title": "HALOBETASOL PROPIONATE CREAM [BRYANT RANCH PREPACK]",
      "spl_version": "2",
      "published_date": "2026-04-27"
    }
  },
  "productid": "85437-008_4d3f3b6d-7f22-1f5c-e063-6294a90a45b3",
  "productndc": "85437-008",
  "dosage_form": "LOTION",
  "orange_book": {
    "appl_no": "208183",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Nov 6, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HALOBETASOL PROPIONATE",
  "proprietary_name": "Halobetasol Propionate",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA208183",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Halobetasol propionate",
  "start_marketing_date": "20260310",
  "active_numerator_strength": ".5"
}

Related drugs

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