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United States · US · US:0591-2579_51bfc674-3cf7-4d5d-9ca8-b7863b2e49b9
Valganciclovir hydrochloride for Oral
Orange BookUNIISPLATC J05AB14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeJ05AB14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110591257920100 mL in 1 BOTTLE, GLASS (0591-2579-20)
Annotations
UNII (FDA Substance ID)
4P3T9QF9NZ
VALGANCICLOVIR HYDROCHLORIDE
RxCUI 283815
Orange Book
A205220
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": "0591-2579_51bfc674-3cf7-4d5d-9ca8-b7863b2e49b9",
"productndc": "0591-2579",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "205220",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG/ML",
"product_no": "001",
"approval_date": "Jul 18, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VALGANCICLOVIR HYDROCHLORIDE",
"proprietary_name": "Valganciclovir hydrochloride for Oral",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA205220",
"marketing_category": "ANDA",
"nonproprietary_name": "Valganciclovir hydrochloride",
"start_marketing_date": "20160826",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J05AB14.
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