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United States · US · US:68682-271_01f93fa6-5fea-4b3e-aa41-e8e0269257ee

Hydrocortisone Butyrate

Orange BookUNIISPLATC D07AB02

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

Identification

ManufacturerOceanside Pharmaceuticals
CountryUS (United States)
ATC codeD07AB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6868227115
    1 TUBE in 1 CARTON (68682-271-15) / 15 g in 1 TUBE
  • ndc11
    6868227145
    1 TUBE in 1 CARTON (68682-271-45) / 45 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
05RMF7YPWN
HYDROCORTISONE BUTYRATE
RxCUI 103468
Orange Book
N018652
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "05RMF7YPWN",
    "rxcui": "103468",
    "inchikey": "BMCQMVFGOVHVNG-TUFAYURCSA-N",
    "display_name": "HYDROCORTISONE BUTYRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "bc751403-94f2-4f9d-b533-cf6186a40ceb": {
      "match": "brand_token",
      "title": "HYDROCORTISONE TABLET [MYLAN PHARMACEUTICALS INC.]",
      "spl_version": "12",
      "published_date": "2026-05-27"
    }
  },
  "productid": "68682-271_01f93fa6-5fea-4b3e-aa41-e8e0269257ee",
  "productndc": "68682-271",
  "dosage_form": "OINTMENT",
  "orange_book": {
    "appl_no": "018652",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "Oct 29, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCORTISONE BUTYRATE",
  "proprietary_name": "Hydrocortisone Butyrate",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA018652",
  "marketing_category": "NDA",
  "nonproprietary_name": "hydrocortisone butyrate",
  "start_marketing_date": "20090901",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code D07AB02.

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