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United States · US · US:0187-0653_dbee276a-6a2e-4565-a106-09a5bcca8778

Duobrii

Orange BookUNIIATC D07AC

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

Identification

ManufacturerBausch Health US, LLC
CountryUS (United States)
ATC codeD07AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0187065301
    1 TUBE in 1 CARTON (0187-0653-01) / 100 g in 1 TUBE
  • ndc11
    0187065303
    6 TUBE in 1 CARTON (0187-0653-03) / 3 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
91A0K1TY3Z
HALOBETASOL PROPIONATE
RxCUI 45318
Orange Book
N209354
AB
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",
  "productid": "0187-0653_dbee276a-6a2e-4565-a106-09a5bcca8778",
  "productndc": "0187-0653",
  "dosage_form": "LOTION",
  "orange_book": {
    "appl_no": "209354",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.01%;0.045%",
        "product_no": "001",
        "approval_date": "Apr 25, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HALOBETASOL PROPIONATE; TAZAROTENE",
  "proprietary_name": "Duobrii",
  "active_ingred_unit": "mg/g; mg/g",
  "application_number": "NDA209354",
  "marketing_category": "NDA",
  "nonproprietary_name": "halobetasol propionate and tazarotene",
  "start_marketing_date": "20190425",
  "active_numerator_strength": ".1; .45"
}

Related drugs

Other records sharing ATC code D07AC.

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