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United States · US · US:59651-444_a1e3ad22-5bc8-45a1-9a9b-1305533be169
Valganciclovir
Orange BookUNIISPLATC J05AB14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ05AB14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159651444011 BOTTLE, GLASS in 1 CARTON (59651-444-01) / 100 mL in 1 BOTTLE, GLASS
Annotations
UNII (FDA Substance ID)
4P3T9QF9NZ
VALGANCICLOVIR HYDROCHLORIDE
RxCUI 283815
Orange Book
A215124
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": "59651-444_a1e3ad22-5bc8-45a1-9a9b-1305533be169",
"productndc": "59651-444",
"dosage_form": "FOR SOLUTION",
"orange_book": {
"appl_no": "215124",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG/ML",
"product_no": "001",
"approval_date": "Nov 17, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VALGANCICLOVIR HYDROCHLORIDE",
"proprietary_name": "Valganciclovir",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA215124",
"marketing_category": "ANDA",
"nonproprietary_name": "Valganciclovir hydrochloride powder,",
"start_marketing_date": "20221117",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J05AB14.
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