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United States · US · US:42571-477_4dab410e-74c6-a8bc-e063-6394a90a03f4

VALGANCICLOVIR

Orange BookUNIISPLATC J05AB14

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeJ05AB14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4257147747
    1 BOTTLE in 1 CARTON (42571-477-47) / 100 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
4P3T9QF9NZ
VALGANCICLOVIR HYDROCHLORIDE
RxCUI 283815
Orange Book
A218838
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": "42571-477_4dab410e-74c6-a8bc-e063-6394a90a03f4",
  "productndc": "42571-477",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "218838",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG/ML",
        "product_no": "001",
        "approval_date": "Mar 19, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VALGANCICLOVIR HYDROCHLORIDE",
  "proprietary_name": "VALGANCICLOVIR",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA218838",
  "marketing_category": "ANDA",
  "nonproprietary_name": "VALGANCICLOVIR",
  "start_marketing_date": "20260601",
  "active_numerator_strength": "50"
}

Related drugs

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