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United States · US · US:62559-111_45040499-9056-45bd-9e0f-113b619fc6ca
Cortenema
Orange BookUNIISPLATC A07EA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA07EA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1162559111077 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-07) / 60 mL in 1 BOTTLE, UNIT-DOSE
- ndc1162559111111 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-11) / 60 mL in 1 BOTTLE, UNIT-DOSE
Annotations
UNII (FDA Substance ID)
WI4X0X7BPJ
HYDROCORTISONE
RxCUI 5492
Orange Book
N016199
AB
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": "RECTAL",
"spl_meta": {
"a307448a-ccc4-41a8-977a-11f28f0bded9": {
"match": "brand_token",
"title": "CORTENEMA (HYDROCORTISONE) ENEMA [ANI PHARMACEUTICALS, INC.]",
"spl_version": "5",
"published_date": "2026-03-05"
}
},
"productid": "62559-111_45040499-9056-45bd-9e0f-113b619fc6ca",
"productndc": "62559-111",
"dosage_form": "ENEMA",
"orange_book": {
"appl_no": "016199",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "100MG/60ML",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROCORTISONE",
"proprietary_name": "Cortenema",
"active_ingred_unit": "mg/60mL",
"application_number": "NDA016199",
"marketing_category": "NDA",
"nonproprietary_name": "Hydrocortisone",
"start_marketing_date": "20120810",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code A07EA02.
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