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United States · US · US:71930-078_2577dbe5-22bd-4da5-9ff8-b88c9dc1ec62

hydrocortisone

Orange BookUNIISPLATC A07EA02

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

Identification

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

Packs · 1

  • ndc11
    7193007850
    50 TABLET in 1 BOTTLE (71930-078-50)

Annotations

UNII (FDA Substance ID)
WI4X0X7BPJ
HYDROCORTISONE
RxCUI 5492
Orange Book
A217160
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": "71930-078_2577dbe5-22bd-4da5-9ff8-b88c9dc1ec62",
  "productndc": "71930-078",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "217160",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Nov 25, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Nov 25, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Nov 25, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCORTISONE",
  "proprietary_name": "hydrocortisone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217160",
  "marketing_category": "ANDA",
  "nonproprietary_name": "hydrocortisone",
  "start_marketing_date": "20221007",
  "active_numerator_strength": "5"
}

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