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United States · US · US:68180-951_ae94a872-5187-4e85-b573-5e9ee9610bff

Hydrocortisone Butyrate

Orange BookUNIISPLATC D07AB02

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

Identification

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

Packs · 2

  • ndc11
    6818095101
    1 BOTTLE in 1 CARTON (68180-951-01) / 59 mL in 1 BOTTLE
  • ndc11
    6818095102
    1 BOTTLE in 1 CARTON (68180-951-02) / 118 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
05RMF7YPWN
HYDROCORTISONE BUTYRATE
RxCUI 103468
Orange Book
A210209
AB
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": "68180-951_ae94a872-5187-4e85-b573-5e9ee9610bff",
  "productndc": "68180-951",
  "dosage_form": "LOTION",
  "orange_book": {
    "appl_no": "210209",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "Aug 17, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCORTISONE BUTYRATE",
  "proprietary_name": "Hydrocortisone Butyrate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA210209",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrocortisone Butyrate",
  "start_marketing_date": "20180817",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code D07AB02.

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