Clobetasol Propionate Cream USP, 0.05%

Orange BookUNIISPLATC D07AD01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeD07AD01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7051843740
30 g in 1 TUBE (70518-4374-0)

Annotations

UNII (FDA Substance ID)

779619577M

CLOBETASOL PROPIONATE

RxCUI 21245

Orange Book

A212982

AB1

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": "70518-4374_4031ce86-d4f7-7ea5-e063-6394a90a0d5a",
  "productndc": "70518-4374",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "212982",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Aug 28, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOBETASOL PROPIONATE",
  "proprietary_name": "Clobetasol Propionate Cream USP, 0.05%",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA212982",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clobetasol Propionate Cream USP, 0.05%",
  "start_marketing_date": "20250627",
  "active_numerator_strength": ".5"
}

Related drugs

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