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United States · US · US:70069-810_48f8965d-d9ca-7c96-e063-6394a90af350
VALGANCICLOVIR HYDROCHLORIDE
Orange BookUNIISPLATC J05AB14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSomerset Therapeutics, LLC
CountryUS (United States)
ATC codeJ05AB14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117006981001100 mL in 1 BOTTLE (70069-810-01)
Annotations
UNII (FDA Substance ID)
GCU97FKN3R
VALGANCICLOVIR
RxCUI 275891
Orange Book
A213306
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "GCU97FKN3R",
"rxcui": "275891",
"inchikey": "WPVFJKSGQUFQAP-GKAPJAKFSA-N",
"display_name": "VALGANCICLOVIR",
"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": "70069-810_48f8965d-d9ca-7c96-e063-6394a90af350",
"productndc": "70069-810",
"dosage_form": "FOR SOLUTION",
"orange_book": {
"appl_no": "213306",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG/ML",
"product_no": "001",
"approval_date": "Jan 31, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VALGANCICLOVIR",
"proprietary_name": "VALGANCICLOVIR HYDROCHLORIDE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA213306",
"marketing_category": "ANDA",
"nonproprietary_name": "VALGANCICLOVIR",
"start_marketing_date": "20220115",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J05AB14.
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