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United States · US · US:0168-0015_22f122cb-16bd-422b-b4d0-bdba8f0b43d8
hydrocortisone
Orange BookUNIISPLATC A07EA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
CountryUS (United States)
ATC codeA07EA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110168001516453.6 g in 1 JAR (0168-0015-16)
- ndc1101680015311 TUBE in 1 CARTON (0168-0015-31) / 28.35 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
WI4X0X7BPJ
HYDROCORTISONE
RxCUI 5492
Orange Book
A080693
AT
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": {
"bc751403-94f2-4f9d-b533-cf6186a40ceb": {
"match": "brand_token",
"title": "HYDROCORTISONE TABLET [MYLAN PHARMACEUTICALS INC.]",
"spl_version": "12",
"published_date": "2026-05-27"
}
},
"productid": "0168-0015_22f122cb-16bd-422b-b4d0-bdba8f0b43d8",
"productndc": "0168-0015",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "080693",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AT",
"strength": "1%",
"product_no": "003",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROCORTISONE",
"proprietary_name": "hydrocortisone",
"active_ingred_unit": "mg/g",
"application_number": "ANDA080693",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydrocortisone",
"start_marketing_date": "19760430",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code A07EA02.
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