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United States · US · US:62484-0015_6eb58656-a29b-4edb-966f-bc9a13a78775
XROMI
Orange BookUNIISPLATC L01XX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNova Laboratories, Ltd.
CountryUS (United States)
ATC codeL01XX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1162484001551 BOTTLE in 1 CARTON (62484-0015-5) / 148 mL in 1 BOTTLE (62484-0015-4)
Annotations
UNII (FDA Substance ID)
X6Q56QN5QC
HYDROXYUREA
RxCUI 5552
Orange Book
N216593
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": {
"4b37d336-86da-4363-aef1-34a7d3ba973b": {
"match": "brand_token",
"title": "XROMI (HYDROXYUREA) SOLUTION [NOVA LABORATORIES, LTD.]",
"spl_version": "10",
"published_date": "2026-02-25"
}
},
"productid": "62484-0015_6eb58656-a29b-4edb-966f-bc9a13a78775",
"productndc": "62484-0015",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "216593",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG/ML",
"product_no": "001",
"approval_date": "Apr 4, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROXYUREA",
"proprietary_name": "XROMI",
"active_ingred_unit": "mg/mL",
"application_number": "NDA216593",
"marketing_category": "NDA",
"nonproprietary_name": "Hydroxyurea",
"start_marketing_date": "20240404",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01XX05.
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