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United States · US · US:61269-480_c70cbfa5-6b69-4fd4-8ad0-e819c8795746
Valcyte
Orange BookUNIISPLATC J05AB14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerH2-Pharma, LLC
CountryUS (United States)
ATC codeJ05AB14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1161269480601 BOTTLE, PLASTIC in 1 CARTON (61269-480-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
4P3T9QF9NZ
VALGANCICLOVIR HYDROCHLORIDE
RxCUI 283815
Orange Book
N021304
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4P3T9QF9NZ",
"rxcui": "283815",
"inchikey": "ZORWARFPXPVJLW-MTFPJWTKSA-N",
"display_name": "VALGANCICLOVIR HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4c517a39-2ded-4c5a-8d56-276853414b31": {
"match": "brand_token",
"title": "VALCYTE (VALGANCICLOVIR) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [H2-PHARMA, LLC]",
"spl_version": "24",
"published_date": "2025-12-10"
}
},
"productid": "61269-480_c70cbfa5-6b69-4fd4-8ad0-e819c8795746",
"productndc": "61269-480",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "021304",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 450MG BASE",
"product_no": "001",
"approval_date": "Mar 29, 2001"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VALGANCICLOVIR HYDROCHLORIDE",
"proprietary_name": "Valcyte",
"active_ingred_unit": "mg/1",
"application_number": "NDA021304",
"marketing_category": "NDA",
"nonproprietary_name": "valganciclovir",
"start_marketing_date": "20010329",
"active_numerator_strength": "450"
}Related drugs
Other records sharing ATC code J05AB14.
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