Halobetasol propionate

Orange BookUNIISPLATC D07AC21

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMayne Pharma

CountryUS (United States)

ATC codeD07AC21

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6830876950
1 CANISTER in 1 CARTON (68308-769-50) / 50 g in 1 CANISTER

Annotations

UNII (FDA Substance ID)

91A0K1TY3Z

HALOBETASOL PROPIONATE

RxCUI 45318

Orange Book

A215266

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": "68308-769_096144f6-b603-41a6-b2a6-760e3a5c43c5",
  "productndc": "68308-769",
  "dosage_form": "AEROSOL, FOAM",
  "orange_book": {
    "appl_no": "215266",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Aug 11, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HALOBETASOL PROPIONATE",
  "proprietary_name": "Halobetasol propionate",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA215266",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Halobetasol propionate",
  "start_marketing_date": "20231127",
  "active_numerator_strength": ".5"
}

Related drugs

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