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United States · US · US:27241-159_6f6211f4-3501-4957-92a1-bd68f2962203

Valganciclovir hydrochloride

Orange BookUNIISPLATC J05AB14

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

Identification

ManufacturerAjanta Pharma USA Inc.
CountryUS (United States)
ATC codeJ05AB14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2724115919
    1 POUCH in 1 CARTON (27241-159-19) / 1 BOTTLE in 1 POUCH / 100 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
4P3T9QF9NZ
VALGANCICLOVIR HYDROCHLORIDE
RxCUI 283815
Orange Book
A212890
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": "27241-159_6f6211f4-3501-4957-92a1-bd68f2962203",
  "productndc": "27241-159",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "212890",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG/ML",
        "product_no": "001",
        "approval_date": "Jan 13, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VALGANCICLOVIR HYDROCHLORIDE",
  "proprietary_name": "Valganciclovir hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA212890",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Valganciclovir hydrochloride",
  "start_marketing_date": "20200113",
  "active_numerator_strength": "50"
}

Related drugs

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