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United States · US · US:65862-753_3d5cd566-06ab-4e83-aba8-f692ff8a23dd
VALGANCICLOVIR HYDROCHLORIDE
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 · 5
- ndc116586275301100 TABLET in 1 BOTTLE (65862-753-01)
- ndc116586275305500 TABLET in 1 BOTTLE (65862-753-05)
- ndc116586275318180 TABLET in 1 BOTTLE (65862-753-18)
- ndc11658627536060 TABLET in 1 BOTTLE (65862-753-60)
- ndc1165862753991000 TABLET in 1 BOTTLE (65862-753-99)
Annotations
UNII (FDA Substance ID)
4P3T9QF9NZ
VALGANCICLOVIR HYDROCHLORIDE
RxCUI 283815
Orange Book
A204750
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": "65862-753_3d5cd566-06ab-4e83-aba8-f692ff8a23dd",
"productndc": "65862-753",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "204750",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 450MG BASE",
"product_no": "001",
"approval_date": "Mar 31, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VALGANCICLOVIR HYDROCHLORIDE",
"proprietary_name": "VALGANCICLOVIR HYDROCHLORIDE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204750",
"marketing_category": "ANDA",
"nonproprietary_name": "VALGANCICLOVIR HYDROCHLORIDE",
"start_marketing_date": "20160331",
"active_numerator_strength": "450"
}Related drugs
Other records sharing ATC code J05AB14.
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