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United States · US · US:83148-064_40290b7e-9b7d-6810-e063-6394a90a2d5d

Clobetasol Propionate (emollient)

Orange BookUNIISPLATC D07AD01

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

Identification

ManufacturerThe J. Molner Company LLC
CountryUS (United States)
ATC codeD07AD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8314806415
    1 TUBE in 1 CARTON (83148-064-15) / 15 g in 1 TUBE
  • ndc11
    8314806430
    1 TUBE in 1 CARTON (83148-064-30) / 30 g in 1 TUBE
  • ndc11
    8314806460
    1 TUBE in 1 CARTON (83148-064-60) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
779619577M
CLOBETASOL PROPIONATE
RxCUI 21245
Orange Book
A209411
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": "83148-064_40290b7e-9b7d-6810-e063-6394a90a2d5d",
  "productndc": "83148-064",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "209411",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Aug 21, 2017"
      }
    ],
    "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": "ANDA209411",
  "marketing_category": "ANDA",
  "nonproprietary_name": "clobetasol propionate",
  "start_marketing_date": "20250929",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code D07AD01.

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