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United States · US · US:71335-1862_18d8f022-a73f-4704-85b0-d9cafc35e035

Valacyclovir Hydrochloride

Orange BookUNIISPLATC J05AB11

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

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
    7133518620
    60 TABLET, FILM COATED in 1 BOTTLE (71335-1862-0)
  • ndc11
    7133518621
    30 TABLET, FILM COATED in 1 BOTTLE (71335-1862-1)
  • ndc11
    7133518622
    21 TABLET, FILM COATED in 1 BOTTLE (71335-1862-2)
  • ndc11
    7133518623
    20 TABLET, FILM COATED in 1 BOTTLE (71335-1862-3)
  • ndc11
    7133518624
    4 TABLET, FILM COATED in 1 BOTTLE (71335-1862-4)
  • ndc11
    7133518625
    10 TABLET, FILM COATED in 1 BOTTLE (71335-1862-5)
  • ndc11
    7133518626
    6 TABLET, FILM COATED in 1 BOTTLE (71335-1862-6)
  • ndc11
    7133518627
    15 TABLET, FILM COATED in 1 BOTTLE (71335-1862-7)
  • ndc11
    7133518628
    8 TABLET, FILM COATED in 1 BOTTLE (71335-1862-8)
  • ndc11
    7133518629
    90 TABLET, FILM COATED in 1 BOTTLE (71335-1862-9)

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": "71335-1862_18d8f022-a73f-4704-85b0-d9cafc35e035",
  "productndc": "71335-1862",
  "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": "g/1",
  "application_number": "ANDA090682",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Valacyclovir Hydrochloride",
  "start_marketing_date": "20100524",
  "active_numerator_strength": "1"
}

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