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United States · US · US:54766-778_43144b43-adf7-3d58-e063-6394a90a2b81
Analpram HC
Orange BookUNIISPLATC D07AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSebela Pharmaceuticals Inc.
CountryUS (United States)
ATC codeD07AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11547667780428.4 g in 1 TUBE, WITH APPLICATOR (54766-778-04)
Annotations
UNII (FDA Substance ID)
3X7931PO74
HYDROCORTISONE ACETATE
RxCUI 27197
Orange Book
A085368
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "3X7931PO74",
"rxcui": "27197",
"inchikey": "ALEXXDVDDISNDU-JZYPGELDSA-N",
"display_name": "HYDROCORTISONE ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"3e5c6728-ece3-40f7-9e36-cff71f168cd8": {
"match": "brand_token",
"title": "ANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [LEGACY PHARMA USA INC.]",
"spl_version": "2",
"published_date": "2026-03-26"
}
},
"productid": "54766-778_43144b43-adf7-3d58-e063-6394a90a2b81",
"productndc": "54766-778",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "085368",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1%;1%",
"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 ACETATE; PRAMOXINE HYDROCHLORIDE",
"proprietary_name": "Analpram HC",
"active_ingred_unit": "mg/g; mg/g",
"application_number": "ANDA085368",
"marketing_category": "ANDA",
"nonproprietary_name": "hydrocortisone acetate and pramoxine hydrochloride",
"start_marketing_date": "20150805",
"active_numerator_strength": "10; 10"
}Related drugs
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