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United States · US · US:80725-810_d30874b9-8639-44b3-a91b-4fcce90ca484
HYDREA
Orange BookUNIISPLATC L01XX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWaylis Therapeutics LLC
CountryUS (United States)
ATC codeL01XX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc118072581010100 CAPSULE in 1 BOTTLE, PLASTIC (80725-810-10)
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": "80725-810_d30874b9-8639-44b3-a91b-4fcce90ca484",
"productndc": "80725-810",
"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": "20250911",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code L01XX05.
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