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United States · US · US:68788-7963_ff9104d2-9ae3-4205-995d-8df11c95e505

Clobetasol Propionate

Orange BookUNIISPLATC D07AD01

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

Identification

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

Packs · 3

  • ndc11
    6878879631
    1 TUBE in 1 CARTON (68788-7963-1) / 15 g in 1 TUBE
  • ndc11
    6878879633
    1 TUBE in 1 CARTON (68788-7963-3) / 30 g in 1 TUBE
  • ndc11
    6878879636
    1 TUBE in 1 CARTON (68788-7963-6) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
779619577M
CLOBETASOL PROPIONATE
RxCUI 21245
Orange Book
A211295
AB
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": {
    "6f930298-e410-4bfb-8c3f-456a1f55f4a9": {
      "match": "brand_token",
      "title": "CLOBETASOL PROPIONATE CREAM [TORRENT PHARMACEUTICALS LIMITED]",
      "spl_version": "10",
      "published_date": "2026-05-11"
    }
  },
  "productid": "68788-7963_ff9104d2-9ae3-4205-995d-8df11c95e505",
  "productndc": "68788-7963",
  "dosage_form": "OINTMENT",
  "orange_book": {
    "appl_no": "211295",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Nov 15, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOBETASOL PROPIONATE",
  "proprietary_name": "Clobetasol Propionate",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA211295",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clobetasol Propionate Ointment, 0.05%",
  "start_marketing_date": "20210719",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code D07AD01.

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