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United States · US · US:0168-0301_60e61fbb-1d01-46ee-8a23-c1af3211f23a

Clobetasol Propionate (emollient)

Orange BookUNIISPLATC D07AD01

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

Identification

ManufacturerE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
CountryUS (United States)
ATC codeD07AD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0168030115
    1 TUBE in 1 CARTON (0168-0301-15) / 15 g in 1 TUBE
  • ndc11
    0168030130
    1 TUBE in 1 CARTON (0168-0301-30) / 30 g in 1 TUBE
  • ndc11
    0168030160
    1 TUBE in 1 CARTON (0168-0301-60) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
779619577M
CLOBETASOL PROPIONATE
RxCUI 21245
Orange Book
A075430
AB2
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": "0168-0301_60e61fbb-1d01-46ee-8a23-c1af3211f23a",
  "productndc": "0168-0301",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "075430",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB2",
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "May 26, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOBETASOL PROPIONATE",
  "proprietary_name": "Clobetasol Propionate (emollient)",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA075430",
  "marketing_category": "ANDA",
  "nonproprietary_name": "clobetasol propionate",
  "start_marketing_date": "19990526",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code D07AD01.

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