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United States · US · US:51672-5281_38f9cadb-290c-0c68-e063-6394a90a38d9

Topicort

Orange BookUNIISPLATC D07AC03

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeD07AC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    5167252810
    1 BOTTLE in 1 CARTON (51672-5281-0) / 6 mL in 1 BOTTLE
  • ndc11
    5167252813
    1 BOTTLE in 1 CARTON (51672-5281-3) / 30 mL in 1 BOTTLE
  • ndc11
    5167252814
    1 BOTTLE in 1 CARTON (51672-5281-4) / 50 mL in 1 BOTTLE
  • ndc11
    5167252816
    2 BOTTLE in 1 CARTON (51672-5281-6) / 50 mL in 1 BOTTLE
  • ndc11
    5167252817
    1 BOTTLE in 1 CARTON (51672-5281-7) / 100 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
4E07GXB7AU
DESOXIMETASONE
RxCUI 3255
Orange Book
N204141
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4E07GXB7AU",
    "rxcui": "3255",
    "inchikey": "VWVSBHGCDBMOOT-IIEHVVJPSA-N",
    "display_name": "DESOXIMETASONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "96dfac6f-540f-4b7d-bcee-7e62088ebc93": {
      "match": "brand_token",
      "title": "TOPICORT (DESOXIMETASONE) OINTMENT [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "11",
      "published_date": "2026-03-16"
    }
  },
  "productid": "51672-5281_38f9cadb-290c-0c68-e063-6394a90a38d9",
  "productndc": "51672-5281",
  "dosage_form": "SPRAY",
  "orange_book": {
    "appl_no": "204141",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.25%",
        "product_no": "001",
        "approval_date": "Apr 11, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DESOXIMETASONE",
  "proprietary_name": "Topicort",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA204141",
  "marketing_category": "NDA",
  "nonproprietary_name": "Desoximetasone",
  "start_marketing_date": "20130411",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code D07AC03.

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