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United States · US · US:71335-0630_375e88d9-f545-4d58-bad6-f0281802d93c

Valacyclovir

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
    7133506300
    60 TABLET, FILM COATED in 1 BOTTLE (71335-0630-0)
  • ndc11
    7133506301
    30 TABLET, FILM COATED in 1 BOTTLE (71335-0630-1)
  • ndc11
    7133506302
    21 TABLET, FILM COATED in 1 BOTTLE (71335-0630-2)
  • ndc11
    7133506303
    20 TABLET, FILM COATED in 1 BOTTLE (71335-0630-3)
  • ndc11
    7133506304
    4 TABLET, FILM COATED in 1 BOTTLE (71335-0630-4)
  • ndc11
    7133506305
    10 TABLET, FILM COATED in 1 BOTTLE (71335-0630-5)
  • ndc11
    7133506306
    6 TABLET, FILM COATED in 1 BOTTLE (71335-0630-6)
  • ndc11
    7133506307
    15 TABLET, FILM COATED in 1 BOTTLE (71335-0630-7)
  • ndc11
    7133506308
    8 TABLET, FILM COATED in 1 BOTTLE (71335-0630-8)
  • ndc11
    7133506309
    90 TABLET, FILM COATED in 1 BOTTLE (71335-0630-9)

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": "71335-0630_375e88d9-f545-4d58-bad6-f0281802d93c",
  "productndc": "71335-0630",
  "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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