Hydrocortisone Butyrate

Orange BookUNIISPLATC D07AB02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerTaro Pharmaceuticals U.S.A., Inc.

CountryUS (United States)

ATC codeD07AB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
5167240831
1 TUBE in 1 CARTON (51672-4083-1) / 15 g in 1 TUBE
ndc11
5167240832
1 TUBE in 1 CARTON (51672-4083-2) / 30 g in 1 TUBE
ndc11
5167240835
5 g in 1 TUBE (51672-4083-5)
ndc11
5167240836
1 TUBE in 1 CARTON (51672-4083-6) / 45 g in 1 TUBE
ndc11
5167240837
1 TUBE in 1 CARTON (51672-4083-7) / 10 g in 1 TUBE

Annotations

UNII (FDA Substance ID)

05RMF7YPWN

HYDROCORTISONE BUTYRATE

RxCUI 103468

Orange Book

A076842

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": "51672-4083_26e4c766-6315-4c55-9814-181258a45ad5",
  "productndc": "51672-4083",
  "dosage_form": "OINTMENT",
  "orange_book": {
    "appl_no": "076842",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "Dec 27, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCORTISONE BUTYRATE",
  "proprietary_name": "Hydrocortisone Butyrate",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA076842",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrocortisone Butyrate",
  "start_marketing_date": "20041227",
  "active_numerator_strength": "1"
}

Related drugs

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