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United States · US · US:71770-105_47d0b61d-ad65-d2e0-e063-6294a90afe50
Siklos
Orange BookUNIISPLATC L01XX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMedunik
CountryUS (United States)
ATC codeL01XX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171770105601 BOTTLE in 1 CARTON (71770-105-60) / 60 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
X6Q56QN5QC
HYDROXYUREA
RxCUI 5552
Orange Book
N208843
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": {
"76957c0d-0f98-4376-bb06-eee651adc09d": {
"match": "brand_token",
"title": "SIKLOS (HYDROXYUREA) TABLET, FILM COATED [MEDUNIK]",
"spl_version": "13",
"published_date": "2026-01-08"
}
},
"productid": "71770-105_47d0b61d-ad65-d2e0-e063-6294a90afe50",
"productndc": "71770-105",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208843",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "001",
"approval_date": "Dec 21, 2017"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1GM",
"product_no": "002",
"approval_date": "Dec 21, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROXYUREA",
"proprietary_name": "Siklos",
"active_ingred_unit": "mg/1",
"application_number": "NDA208843",
"marketing_category": "NDA",
"nonproprietary_name": "hydroxyurea",
"start_marketing_date": "20201015",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01XX05.
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