Valacyclovir

Orange BookUNIISPLATC J05AB11

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeJ05AB11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
8280400906
6 TABLET in 1 BOTTLE (82804-009-06)
ndc11
8280400910
10 TABLET in 1 BOTTLE (82804-009-10)
ndc11
8280400921
21 TABLET in 1 BOTTLE (82804-009-21)
ndc11
8280400930
30 TABLET in 1 BOTTLE (82804-009-30)
ndc11
8280400960
60 TABLET in 1 BOTTLE (82804-009-60)
ndc11
8280400990
90 TABLET in 1 BOTTLE (82804-009-90)

Annotations

UNII (FDA Substance ID)

G447S0T1VC

VALACYCLOVIR HYDROCHLORIDE

RxCUI 236081

Orange Book

A209553

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "G447S0T1VC",
    "rxcui": "236081",
    "inchikey": "ZCDDBUOENGJMLV-QRPNPIFTSA-N",
    "display_name": "VALACYCLOVIR HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "021ab9d0-7b75-40cf-afde-446942d64388": {
      "match": "brand_token",
      "title": "VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR) TABLET, FILM COATED [SAFECOR HEALTH LLC]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "82804-009_dcd80515-07e5-476c-b923-22bb48af61f3",
  "productndc": "82804-009",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209553",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "001",
        "approval_date": "Mar 18, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1GM BASE",
        "product_no": "002",
        "approval_date": "Mar 18, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VALACYCLOVIR HYDROCHLORIDE",
  "proprietary_name": "Valacyclovir",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209553",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Valacyclovir",
  "start_marketing_date": "20230214",
  "active_numerator_strength": "500"
}

Related drugs

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