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United States · US · US:69315-312_614fdcc8-43c2-4c42-a7fe-016844f338d8
Procto-Med HC
Orange BookUNIISPLATC A07EA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLeading Pharma, LLC
CountryUS (United States)
ATC codeA07EA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169315312281 TUBE in 1 CARTON (69315-312-28) / 28 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
WI4X0X7BPJ
HYDROCORTISONE
RxCUI 5492
Orange Book
A085025
AT
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": {
"4b972547-5bd4-155d-e063-6394a90a03ee": {
"match": "brand_token",
"title": "PROCTO-MED HC (HYDROCORTISONE) CREAM [NUCARE PHARMACEUTICALS,INC.]",
"spl_version": "2",
"published_date": "2026-03-03"
}
},
"productid": "69315-312_614fdcc8-43c2-4c42-a7fe-016844f338d8",
"productndc": "69315-312",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "085025",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "2.5%",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROCORTISONE",
"proprietary_name": "Procto-Med HC",
"active_ingred_unit": "mg/g",
"application_number": "ANDA085025",
"marketing_category": "ANDA",
"nonproprietary_name": "HYDROCORTISONE",
"start_marketing_date": "20200214",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code A07EA02.
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