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United States · US · US:42571-477_4dab410e-74c6-a8bc-e063-6394a90a03f4
VALGANCICLOVIR
Orange BookUNIISPLATC J05AB14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeJ05AB14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1142571477471 BOTTLE in 1 CARTON (42571-477-47) / 100 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
4P3T9QF9NZ
VALGANCICLOVIR HYDROCHLORIDE
RxCUI 283815
Orange Book
A218838
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": "42571-477_4dab410e-74c6-a8bc-e063-6394a90a03f4",
"productndc": "42571-477",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "218838",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG/ML",
"product_no": "001",
"approval_date": "Mar 19, 2026"
}
],
"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": "ANDA218838",
"marketing_category": "ANDA",
"nonproprietary_name": "VALGANCICLOVIR",
"start_marketing_date": "20260601",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J05AB14.
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