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United States · US · US:71863-116_4e6ce593-4984-4a6f-e063-6394a90a0169
Khindivi
Orange BookUNIISPLATC A07EA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEton Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA07EA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171863116161 mL in 1 BOTTLE (71863-116-16)
Annotations
UNII (FDA Substance ID)
WI4X0X7BPJ
HYDROCORTISONE
RxCUI 5492
Orange Book
N218980
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": "ORAL",
"spl_meta": {
"1ef80500-8386-40ee-b608-516cd687b376": {
"match": "brand_token",
"title": "KHINDIVI (HYDROCORTISONE) SOLUTION [ETON PHARMACEUTICALS, INC.]",
"spl_version": "4",
"published_date": "2026-04-22"
}
},
"productid": "71863-116_4e6ce593-4984-4a6f-e063-6394a90a0169",
"productndc": "71863-116",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "218980",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "May 28, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROCORTISONE",
"proprietary_name": "Khindivi",
"active_ingred_unit": "mg/mL",
"application_number": "NDA218980",
"marketing_category": "NDA",
"nonproprietary_name": "Hydrocortisone",
"start_marketing_date": "20250602",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code A07EA02.
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