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United States · US · US:68682-384_36d82d8e-8303-bf39-e063-6394a90a2fab
Hydrocortisone Butyrate
Orange BookUNIISPLATC D07AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOceanside Pharmaceuticals
CountryUS (United States)
ATC codeD07AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1168682384451 TUBE in 1 CARTON (68682-384-45) / 45 g in 1 TUBE
- ndc1168682384601 TUBE in 1 CARTON (68682-384-60) / 60 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
05RMF7YPWN
HYDROCORTISONE BUTYRATE
RxCUI 103468
Orange Book
N020769
AB2
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "05RMF7YPWN",
"rxcui": "103468",
"inchikey": "BMCQMVFGOVHVNG-TUFAYURCSA-N",
"display_name": "HYDROCORTISONE BUTYRATE",
"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": "68682-384_36d82d8e-8303-bf39-e063-6394a90a2fab",
"productndc": "68682-384",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "020769",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB2",
"strength": "0.1%",
"product_no": "001",
"approval_date": "Sep 8, 1997"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROCORTISONE BUTYRATE",
"proprietary_name": "Hydrocortisone Butyrate",
"active_ingred_unit": "mg/g",
"application_number": "NDA020769",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "HYDROCORTISONE BUTYRATE",
"start_marketing_date": "20130703",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code D07AB02.
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