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United States · US · US:71151-003_d94fb558-d963-5c7a-e053-2a95a90a04b4

VALGANCICLOVIR

Orange BookUNIISPLATC J05AB14

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

Identification

Manufacturerairis PHARMA PVT LTD
CountryUS (United States)
ATC codeJ05AB14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7115100301
    100 mL in 1 BOTTLE, DISPENSING (71151-003-01)

Annotations

UNII (FDA Substance ID)
4P3T9QF9NZ
VALGANCICLOVIR HYDROCHLORIDE
RxCUI 283815
Orange Book
A210169
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": "71151-003_d94fb558-d963-5c7a-e053-2a95a90a04b4",
  "productndc": "71151-003",
  "dosage_form": "FOR SOLUTION",
  "orange_book": {
    "appl_no": "210169",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG/ML",
        "product_no": "001",
        "approval_date": "Feb 17, 2022"
      }
    ],
    "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": "ANDA210169",
  "marketing_category": "ANDA",
  "nonproprietary_name": "valganciclovir",
  "start_marketing_date": "20220228",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code J05AB14.

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