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United States · US · US:65649-501_62bfc47a-1d14-4dd2-8020-56e01f4e89a7
Proctocort
Orange BookUNIISPLATC A07EA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSalix Pharmaceuticals, Inc
CountryUS (United States)
ATC codeA07EA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165649501301 TUBE in 1 CARTON (65649-501-30) / 28.35 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": {
"a2e1222a-ab91-4382-a210-7dfdd6de1407": {
"match": "brand_token",
"title": "PROCTOCORT (HYDROCORTISONE ACETATE) SUPPOSITORY [SALIX PHARMACEUTICALS, INC]",
"spl_version": "4",
"published_date": "2024-09-19"
}
},
"productid": "65649-501_62bfc47a-1d14-4dd2-8020-56e01f4e89a7",
"productndc": "65649-501",
"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": "Proctocort",
"active_ingred_unit": "mg/g",
"application_number": "ANDA080706",
"marketing_category": "ANDA",
"nonproprietary_name": "HYDROCORTISONE",
"start_marketing_date": "20040601",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code A07EA02.
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