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United States · US · US:65862-753_3d5cd566-06ab-4e83-aba8-f692ff8a23dd

VALGANCICLOVIR HYDROCHLORIDE

Orange BookUNIISPLATC J05AB14

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

Identification

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

Packs · 5

  • ndc11
    6586275301
    100 TABLET in 1 BOTTLE (65862-753-01)
  • ndc11
    6586275305
    500 TABLET in 1 BOTTLE (65862-753-05)
  • ndc11
    6586275318
    180 TABLET in 1 BOTTLE (65862-753-18)
  • ndc11
    6586275360
    60 TABLET in 1 BOTTLE (65862-753-60)
  • ndc11
    6586275399
    1000 TABLET in 1 BOTTLE (65862-753-99)

Annotations

UNII (FDA Substance ID)
4P3T9QF9NZ
VALGANCICLOVIR HYDROCHLORIDE
RxCUI 283815
Orange Book
A204750
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": "65862-753_3d5cd566-06ab-4e83-aba8-f692ff8a23dd",
  "productndc": "65862-753",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204750",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 450MG BASE",
        "product_no": "001",
        "approval_date": "Mar 31, 2016"
      }
    ],
    "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": "ANDA204750",
  "marketing_category": "ANDA",
  "nonproprietary_name": "VALGANCICLOVIR HYDROCHLORIDE",
  "start_marketing_date": "20160331",
  "active_numerator_strength": "450"
}

Related drugs

Other records sharing ATC code J05AB14.

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