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United States · US · US:49884-724_4413d36e-3573-4ba9-9baa-c0bbd5e254d5
Hydroxyurea
Orange BookUNIISPLATC L01XX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPar Health USA, LLC
CountryUS (United States)
ATC codeL01XX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114988472401100 CAPSULE in 1 BOTTLE (49884-724-01)
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": "49884-724_4413d36e-3573-4ba9-9baa-c0bbd5e254d5",
"productndc": "49884-724",
"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.
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