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United States · US · US:60429-846_1274f28f-fd5b-f5f1-e063-6394a90ac7d2

Valganciclovir

Orange BookUNIISPLATC J05AB14

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

Identification

ManufacturerGolden State Medical Supply, Inc.
CountryUS (United States)
ATC codeJ05AB14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6042984660
    60 TABLET, FILM COATED in 1 BOTTLE (60429-846-60)

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": "60429-846_1274f28f-fd5b-f5f1-e063-6394a90ac7d2",
  "productndc": "60429-846",
  "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": "20141104",
  "active_numerator_strength": "450"
}

Related drugs

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