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United States · US · US:63629-1952_4de25392-8ba0-6ab1-e063-6294a90ad1bd

Hydrocortisone

Orange BookUNIISPLATC A07EA02

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeA07EA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6362919521
    1 TUBE in 1 CARTON (63629-1952-1) / 30 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
WI4X0X7BPJ
HYDROCORTISONE
RxCUI 5492
Orange Book
A080706
ATAT
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": "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": "63629-1952_4de25392-8ba0-6ab1-e063-6294a90ad1bd",
  "productndc": "63629-1952",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "080706",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "1%",
        "product_no": "006",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "2.5%",
        "product_no": "007",
        "approval_date": "Jan 5, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCORTISONE",
  "proprietary_name": "Hydrocortisone",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA080706",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrocortisone",
  "start_marketing_date": "20160401",
  "active_numerator_strength": "25"
}

Related drugs

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