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United States · US · US:69238-1532_df6ce06d-306e-47db-8130-24bc017bcf6e

Clobetasol Propionate

Orange BookUNIISPLATC D07AD01

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeD07AD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6923815323
    1 TUBE in 1 CARTON (69238-1532-3) / 30 g in 1 TUBE
  • ndc11
    6923815324
    1 TUBE in 1 CARTON (69238-1532-4) / 45 g in 1 TUBE
  • ndc11
    6923815325
    1 TUBE in 1 CARTON (69238-1532-5) / 15 g in 1 TUBE
  • ndc11
    6923815326
    1 TUBE in 1 CARTON (69238-1532-6) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
779619577M
CLOBETASOL PROPIONATE
RxCUI 21245
Orange Book
A211256
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": "69238-1532_df6ce06d-306e-47db-8130-24bc017bcf6e",
  "productndc": "69238-1532",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "211256",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Dec 26, 2018"
      }
    ],
    "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": "ANDA211256",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clobetasol Propionate",
  "start_marketing_date": "20181228",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code D07AD01.

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