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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

  • ndc11
    7006981001
    100 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

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