Valacyclovir Hydrochloride

Orange BookUNIISPLATC J05AB11

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeJ05AB11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7642005312
12 TABLET, FILM COATED in 1 BOTTLE (76420-053-12)
ndc11
7642005330
30 TABLET, FILM COATED in 1 BOTTLE (76420-053-30)

Annotations

UNII (FDA Substance ID)

G447S0T1VC

VALACYCLOVIR HYDROCHLORIDE

RxCUI 236081

Orange Book

A090682

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": "76420-053_b26ab5c7-62e8-3fc4-e053-2a95a90abb45",
  "productndc": "76420-053",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090682",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "001",
        "approval_date": "May 24, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1GM BASE",
        "product_no": "002",
        "approval_date": "May 24, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VALACYCLOVIR HYDROCHLORIDE",
  "proprietary_name": "Valacyclovir Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090682",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Valacyclovir Hydrochloride",
  "start_marketing_date": "20100524",
  "active_numerator_strength": "500"
}

Related drugs

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