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United States · US · US:27241-158_f537ddb1-f868-4bef-937b-e520b04e26a0
Valganciclovir
Orange BookUNIISPLATC J05AB14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAjanta Pharma USA Inc.
CountryUS (United States)
ATC codeJ05AB14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11272411586060 TABLET in 1 BOTTLE (27241-158-60)
Annotations
UNII (FDA Substance ID)
4P3T9QF9NZ
VALGANCICLOVIR HYDROCHLORIDE
RxCUI 283815
Orange Book
A212234
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": {
"facbcc41-52cf-4433-b3fc-9bf8f06dcdd9": {
"match": "brand_token",
"title": "VALGANCICLOVIR POWDER, FOR SOLUTION [MICRO LABS LIMITED]",
"spl_version": "1",
"published_date": "2026-06-02"
}
},
"productid": "27241-158_f537ddb1-f868-4bef-937b-e520b04e26a0",
"productndc": "27241-158",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "212234",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 450MG BASE",
"product_no": "001",
"approval_date": "Dec 26, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VALGANCICLOVIR HYDROCHLORIDE",
"proprietary_name": "Valganciclovir",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212234",
"marketing_category": "ANDA",
"nonproprietary_name": "Valganciclovir",
"start_marketing_date": "20191226",
"active_numerator_strength": "450"
}Related drugs
Other records sharing ATC code J05AB14.
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