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United States · US · US:71297-241_3b007d65-4f52-825f-e063-6294a90a71bb

Hydrocortisone Acetate Cream

Orange BookUNIISPLATC A07EA02

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

Identification

ManufacturerAllegis Holdings LLC
CountryUS (United States)
ATC codeA07EA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7129724101
    28.4 g in 1 CARTON (71297-241-01)

Annotations

UNII (FDA Substance ID)
3X7931PO74
HYDROCORTISONE ACETATE
RxCUI 27197
Orange Book
A040396
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "3X7931PO74",
    "rxcui": "27197",
    "inchikey": "ALEXXDVDDISNDU-JZYPGELDSA-N",
    "display_name": "HYDROCORTISONE ACETATE",
    "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": "71297-241_3b007d65-4f52-825f-e063-6294a90a71bb",
  "productndc": "71297-241",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "040396",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2.5%",
        "product_no": "001",
        "approval_date": "Feb 27, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCORTISONE ACETATE",
  "proprietary_name": "Hydrocortisone Acetate Cream",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA040396",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrocortisone Acetate Cream",
  "start_marketing_date": "20250728",
  "active_numerator_strength": "20"
}

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