Valacyclovir Hydrochloride

Orange BookUNIISPLATC J05AB11

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeJ05AB11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7133513410
60 TABLET, FILM COATED in 1 BOTTLE (71335-1341-0)
ndc11
7133513411
15 TABLET, FILM COATED in 1 BOTTLE (71335-1341-1)
ndc11
7133513412
10 TABLET, FILM COATED in 1 BOTTLE (71335-1341-2)
ndc11
7133513413
4 TABLET, FILM COATED in 1 BOTTLE (71335-1341-3)
ndc11
7133513414
7 TABLET, FILM COATED in 1 BOTTLE (71335-1341-4)
ndc11
7133513415
20 TABLET, FILM COATED in 1 BOTTLE (71335-1341-5)
ndc11
7133513416
30 TABLET, FILM COATED in 1 BOTTLE (71335-1341-6)
ndc11
7133513417
8 TABLET, FILM COATED in 1 BOTTLE (71335-1341-7)
ndc11
7133513418
90 TABLET, FILM COATED in 1 BOTTLE (71335-1341-8)
ndc11
7133513419
14 TABLET, FILM COATED in 1 BOTTLE (71335-1341-9)

Annotations

UNII (FDA Substance ID)

G447S0T1VC

VALACYCLOVIR HYDROCHLORIDE

RxCUI 236081

Orange Book

A078518

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": "71335-1341_97d0395b-b5bd-45d9-bd2b-a1791a787a5d",
  "productndc": "71335-1341",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078518",
    "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": "ANDA078518",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Valacyclovir Hydrochloride",
  "start_marketing_date": "20100524",
  "active_numerator_strength": "500"
}

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