🇺🇸
United States · US · US:0904-6939_554e6427-7d26-4f99-b69b-10468b9bb014
Hydroxyurea
Orange BookUNIISPLATC L01XX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeL01XX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110904693961100 BLISTER PACK in 1 CARTON (0904-6939-61) / 1 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
X6Q56QN5QC
HYDROXYUREA
RxCUI 5552
Orange Book
A075340
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": {
"9e1bdd4b-043a-4cf6-b1ff-8de49e02b7a6": {
"match": "brand_token",
"title": "HYDROXYUREA CAPSULE [PAR HEALTH USA, LLC]",
"spl_version": "23",
"published_date": "2026-05-15"
}
},
"productid": "0904-6939_554e6427-7d26-4f99-b69b-10468b9bb014",
"productndc": "0904-6939",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "075340",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Feb 24, 1999"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROXYUREA",
"proprietary_name": "Hydroxyurea",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075340",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyurea",
"start_marketing_date": "19990224",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code L01XX05.
Access this data programmatically
Query Hydroxyurea and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.