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United States · US · US:68040-713_a5624741-36f8-4f2f-8e8b-b235571727ae

Impoyz

Orange BookUNIISPLATC D07AD01

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

Identification

ManufacturerPrimus Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeD07AD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6804071338
    1 TUBE in 1 CARTON (68040-713-38) / 100 g in 1 TUBE
  • ndc11
    6804071344
    20 TUBE in 1 CARTON (68040-713-44) / 2.5 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
779619577M
CLOBETASOL PROPIONATE
RxCUI 21245
Orange Book
N209483
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "779619577M",
    "rxcui": "21245",
    "inchikey": "CBGUOGMQLZIXBE-XGQKBEPLSA-N",
    "display_name": "CLOBETASOL PROPIONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "40173654-334e-4618-847b-6a1e030cd2fd": {
      "match": "brand_token",
      "title": "IMPOYZ (CLOBETASOL PROPIONATE) CREAM [PRIMUS PHARMACEUTICALS, INC.]",
      "spl_version": "3",
      "published_date": "2024-01-31"
    }
  },
  "productid": "68040-713_a5624741-36f8-4f2f-8e8b-b235571727ae",
  "productndc": "68040-713",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "209483",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.025%",
        "product_no": "001",
        "approval_date": "Nov 28, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOBETASOL PROPIONATE",
  "proprietary_name": "Impoyz",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA209483",
  "marketing_category": "NDA",
  "nonproprietary_name": "clobetasol propionate",
  "start_marketing_date": "20211201",
  "active_numerator_strength": ".25"
}

Related drugs

Other records sharing ATC code D07AD01.

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