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United States · US · US:81046-0319_32e1b12d-ed8c-33a3-e063-6294a90a3109

CLOBETASOL PROPIONATE

Orange BookUNIISPLATC D07AD01

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

Identification

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

Packs · 1

  • ndc11
    8104603191
    1 BOTTLE, DROPPER in 1 CARTON (81046-0319-1) / 3.5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
779619577M
CLOBETASOL PROPIONATE
RxCUI 21245
Orange Book
N218158
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": "OPHTHALMIC",
  "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": "81046-0319_32e1b12d-ed8c-33a3-e063-6294a90a3109",
  "productndc": "81046-0319",
  "dosage_form": "SUSPENSION/ DROPS",
  "orange_book": {
    "appl_no": "218158",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Mar 4, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOBETASOL PROPIONATE",
  "proprietary_name": "CLOBETASOL PROPIONATE",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA218158",
  "marketing_category": "NDA",
  "nonproprietary_name": "CLOBETASOL PROPIONATE",
  "start_marketing_date": "20240325",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code D07AD01.

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