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United States · US · US:72789-452_4d7b15fb-01ce-665a-e063-6294a90abf2a

Valacyclovir

Orange BookUNIISPLATC J05AB11

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ05AB11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7278945221
    21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-452-21)

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": "72789-452_4d7b15fb-01ce-665a-e063-6294a90abf2a",
  "productndc": "72789-452",
  "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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