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United States · US · US:83148-012_407bc1b6-5851-1b87-e063-6294a90a02da
Hydrocortisone Butyrate
Orange BookUNIISPLATC D07AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerThe J. Molner Company LLC
CountryUS (United States)
ATC codeD07AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1183148012021 BOTTLE in 1 CARTON (83148-012-02) / 59 mL in 1 BOTTLE
- ndc1183148012041 BOTTLE in 1 CARTON (83148-012-04) / 118 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
05RMF7YPWN
HYDROCORTISONE BUTYRATE
RxCUI 103468
Orange Book
A209556
AB
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": "83148-012_407bc1b6-5851-1b87-e063-6294a90a02da",
"productndc": "83148-012",
"dosage_form": "LOTION",
"orange_book": {
"appl_no": "209556",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.1%",
"product_no": "001",
"approval_date": "Nov 21, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROCORTISONE BUTYRATE",
"proprietary_name": "Hydrocortisone Butyrate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA209556",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydrocortisone Butyrate",
"start_marketing_date": "20231106",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code D07AB02.
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