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United States · US · US:68084-965_22ca12d3-7404-28f7-e063-6394a90a94bf
Valganciclovir
Orange BookUNIISPLATC J05AB14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeJ05AB14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11680849651920 BLISTER PACK in 1 CARTON (68084-965-19) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-965-18)
- ndc11680849652530 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-965-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-965-95)
Annotations
UNII (FDA Substance ID)
4P3T9QF9NZ
VALGANCICLOVIR HYDROCHLORIDE
RxCUI 283815
Orange Book
A203511
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": "68084-965_22ca12d3-7404-28f7-e063-6394a90a94bf",
"productndc": "68084-965",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "203511",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 450MG BASE",
"product_no": "001",
"approval_date": "Nov 4, 2014"
}
],
"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": "ANDA203511",
"marketing_category": "ANDA",
"nonproprietary_name": "Valganciclovir",
"start_marketing_date": "20150107",
"active_numerator_strength": "450"
}Related drugs
Other records sharing ATC code J05AB14.
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