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United States · US · US:59762-0073_ac03d89e-21e7-4bd4-8355-cafa20808953

Hydrocortisone

Orange BookUNIISPLATC A07EA02

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

Identification

ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA07EA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5976200731
    50 TABLET in 1 BOTTLE (59762-0073-1)

Annotations

UNII (FDA Substance ID)
WI4X0X7BPJ
HYDROCORTISONE
RxCUI 5492
Orange Book
N008697
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "WI4X0X7BPJ",
    "rxcui": "5492",
    "inchikey": "JYGXADMDTFJGBT-VWUMJDOOSA-N",
    "display_name": "HYDROCORTISONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "59762-0073_ac03d89e-21e7-4bd4-8355-cafa20808953",
  "productndc": "59762-0073",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "008697",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCORTISONE",
  "proprietary_name": "Hydrocortisone",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA008697",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "hydrocortisone",
  "start_marketing_date": "20130220",
  "active_numerator_strength": "5"
}

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