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United States · US · US:43598-356_2fbdd00d-733b-49f9-70b4-c1aefa75d6a4

valganciclovir hydrochloride

Orange BookUNIISPLATC J05AB14

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

Identification

ManufacturerDr. Reddy's Laboratories Inc
CountryUS (United States)
ATC codeJ05AB14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4359835630
    30 TABLET in 1 BOTTLE (43598-356-30)
  • ndc11
    4359835660
    60 TABLET in 1 BOTTLE (43598-356-60)

Annotations

UNII (FDA Substance ID)
4P3T9QF9NZ
VALGANCICLOVIR HYDROCHLORIDE
RxCUI 283815
Orange Book
A206876
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": "43598-356_2fbdd00d-733b-49f9-70b4-c1aefa75d6a4",
  "productndc": "43598-356",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206876",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 450MG BASE",
        "product_no": "001",
        "approval_date": "Dec 12, 2017"
      }
    ],
    "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": "ANDA206876",
  "marketing_category": "ANDA",
  "nonproprietary_name": "valganciclovir hydrochloride",
  "start_marketing_date": "20171212",
  "active_numerator_strength": "450"
}

Related drugs

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