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United States · US · US:71921-210_cc6c4939-7908-439c-b1b8-6b52e826c7a5
Valganciclovir
Orange BookUNIISPLATC J05AB14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFlorida Pharmaceutical Products, LLC
CountryUS (United States)
ATC codeJ05AB14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171921210121 BOTTLE in 1 CARTON (71921-210-12) / 100 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
GCU97FKN3R
VALGANCICLOVIR
RxCUI 275891
Orange Book
A216317
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": "71921-210_cc6c4939-7908-439c-b1b8-6b52e826c7a5",
"productndc": "71921-210",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "216317",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG/ML",
"product_no": "001",
"approval_date": "Apr 11, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VALGANCICLOVIR",
"proprietary_name": "Valganciclovir",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA216317",
"marketing_category": "ANDA",
"nonproprietary_name": "Valganciclovir",
"start_marketing_date": "20230701",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J05AB14.
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