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United States · US · US:61269-835_936d1231-1661-44c9-9eb9-0de1d3bf48cb
HYDREA
Orange BookUNIISPLATC L01XX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerH2-Pharma LLC
CountryUS (United States)
ATC codeL01XX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116126983510100 CAPSULE in 1 BOTTLE (61269-835-10)
Annotations
UNII (FDA Substance ID)
X6Q56QN5QC
HYDROXYUREA
RxCUI 5552
Orange Book
N016295
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "X6Q56QN5QC",
"rxcui": "5552",
"inchikey": "VSNHCAURESNICA-UHFFFAOYSA-N",
"display_name": "HYDROXYUREA",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"6053c775-68de-45e4-9af9-33b18fd0e140": {
"match": "brand_token",
"title": "HYDREA (HYDROXYUREA) CAPSULE [H2-PHARMA LLC]",
"spl_version": "21",
"published_date": "2026-01-28"
}
},
"productid": "61269-835_936d1231-1661-44c9-9eb9-0de1d3bf48cb",
"productndc": "61269-835",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "016295",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "200MG",
"product_no": "002",
"approval_date": "Feb 25, 1998"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "300MG",
"product_no": "003",
"approval_date": "Feb 25, 1998"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "400MG",
"product_no": "004",
"approval_date": "Feb 25, 1998"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROXYUREA",
"proprietary_name": "HYDREA",
"active_ingred_unit": "mg/1",
"application_number": "NDA016295",
"marketing_category": "NDA",
"nonproprietary_name": "HYDROXYUREA",
"start_marketing_date": "20090601",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code L01XX05.
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