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 · 9

ndc11
6318795004
4 TABLET, FILM COATED in 1 BOTTLE (63187-950-04)
ndc11
6318795006
6 TABLET, FILM COATED in 1 BOTTLE (63187-950-06)
ndc11
6318795010
10 TABLET, FILM COATED in 1 BOTTLE (63187-950-10)
ndc11
6318795014
14 TABLET, FILM COATED in 1 BOTTLE (63187-950-14)
ndc11
6318795020
20 TABLET, FILM COATED in 1 BOTTLE (63187-950-20)
ndc11
6318795021
21 TABLET, FILM COATED in 1 BOTTLE (63187-950-21)
ndc11
6318795030
30 TABLET, FILM COATED in 1 BOTTLE (63187-950-30)
ndc11
6318795060
60 TABLET, FILM COATED in 1 BOTTLE (63187-950-60)
ndc11
6318795090
90 TABLET, FILM COATED in 1 BOTTLE (63187-950-90)

Annotations

UNII (FDA Substance ID)

G447S0T1VC

VALACYCLOVIR HYDROCHLORIDE

RxCUI 236081

Orange Book

A203047

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": "63187-950_441151ec-31f4-413c-8764-11fc16fb2ada",
  "productndc": "63187-950",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203047",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "001",
        "approval_date": "Apr 8, 2015"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1GM BASE",
        "product_no": "002",
        "approval_date": "Apr 8, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VALACYCLOVIR HYDROCHLORIDE",
  "proprietary_name": "Valacyclovir",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA203047",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Valacyclovir",
  "start_marketing_date": "20150525",
  "active_numerator_strength": "1"
}

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