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United States · US · US:50633-330_2e671cf8-09be-ac40-e063-6294a90aaf8f
XURIDEN
Orange BookUNIISPLATC A16AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBTG International Inc
CountryUS (United States)
ATC codeA16AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11506333303030 PACKET in 1 CARTON (50633-330-30) / 2 g in 1 PACKET (50633-330-02)
Annotations
UNII (FDA Substance ID)
2WP61F175M
URIDINE TRIACETATE
RxCUI 1665222
Orange Book
N208169
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2WP61F175M",
"rxcui": "1665222",
"inchikey": "AUFUWRKPQLGTGF-FMKGYKFTSA-N",
"display_name": "URIDINE TRIACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"88ca4d2b-3905-474b-9fd6-c81474f2fb4b": {
"match": "brand_token",
"title": "XURIDEN (URIDINE TRIACETATE) GRANULE [BTG INTERNATIONAL INC]",
"spl_version": "4",
"published_date": "2025-02-21"
}
},
"productid": "50633-330_2e671cf8-09be-ac40-e063-6294a90aaf8f",
"productndc": "50633-330",
"dosage_form": "GRANULE",
"orange_book": {
"appl_no": "208169",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2GM/PACKET",
"product_no": "001",
"approval_date": "Sep 4, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "URIDINE TRIACETATE",
"proprietary_name": "XURIDEN",
"active_ingred_unit": "mg/g",
"application_number": "NDA208169",
"marketing_category": "NDA",
"nonproprietary_name": "uridine triacetate",
"start_marketing_date": "20240531",
"active_numerator_strength": "951"
}Related drugs
Other records sharing ATC code A16AX13.
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