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United States · US · US:0168-0146_d4641721-bb32-4cf7-b17f-78886ffbce17
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
- ndc110168014616454 g in 1 JAR (0168-0146-16)
- ndc11016801463029 g in 1 TUBE (0168-0146-30)
Annotations
UNII (FDA Substance ID)
WI4X0X7BPJ
HYDROCORTISONE
RxCUI 5492
Orange Book
A081203
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": "0168-0146_d4641721-bb32-4cf7-b17f-78886ffbce17",
"productndc": "0168-0146",
"dosage_form": "OINTMENT",
"orange_book": {
"appl_no": "081203",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AT",
"strength": "2.5%",
"product_no": "001",
"approval_date": "May 28, 1993"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROCORTISONE",
"proprietary_name": "Hydrocortisone",
"active_ingred_unit": "mg/g",
"application_number": "ANDA081203",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydrocortisone",
"start_marketing_date": "19930528",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code A07EA02.
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