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United States · US · US:0713-0339_163af771-5ae8-ac38-e063-6294a90ae5bd

Halobetasol Propionate

Orange BookUNIISPLATC D07AC21

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

Identification

ManufacturerCosette Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeD07AC21
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0713033915
    1 TUBE in 1 CARTON (0713-0339-15) / 15 g in 1 TUBE
  • ndc11
    0713033986
    1 TUBE in 1 CARTON (0713-0339-86) / 50 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
91A0K1TY3Z
HALOBETASOL PROPIONATE
RxCUI 45318
Orange Book
A077109
AB
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": "0713-0339_163af771-5ae8-ac38-e063-6294a90ae5bd",
  "productndc": "0713-0339",
  "dosage_form": "OINTMENT",
  "orange_book": {
    "appl_no": "077109",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Jun 14, 2005"
      }
    ],
    "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": "ANDA077109",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Halobetasol Propionate",
  "start_marketing_date": "20050614",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code D07AC21.

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