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United States · US · US:85766-026_4a16992e-bbaa-c4b0-e063-6294a90af825

Valacyclovir Hydrochloride

Orange BookUNIISPLATC J05AB11

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

Identification

ManufacturerSportpharm LLC
CountryUS (United States)
ATC codeJ05AB11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 14

  • ndc11
    8576602601
    100 TABLET, FILM COATED in 1 BOTTLE (85766-026-01)
  • ndc11
    8576602602
    2 TABLET, FILM COATED in 1 BOTTLE (85766-026-02)
  • ndc11
    8576602604
    4 TABLET, FILM COATED in 1 BOTTLE (85766-026-04)
  • ndc11
    8576602605
    500 TABLET, FILM COATED in 1 BOTTLE (85766-026-05)
  • ndc11
    8576602606
    6 TABLET, FILM COATED in 1 BOTTLE (85766-026-06)
  • ndc11
    8576602607
    7 TABLET, FILM COATED in 1 BOTTLE (85766-026-07)
  • ndc11
    8576602610
    10 TABLET, FILM COATED in 1 BOTTLE (85766-026-10)
  • ndc11
    8576602614
    14 TABLET, FILM COATED in 1 BOTTLE (85766-026-14)
  • ndc11
    8576602615
    15 TABLET, FILM COATED in 1 BOTTLE (85766-026-15)
  • ndc11
    8576602620
    20 TABLET, FILM COATED in 1 BOTTLE (85766-026-20)
  • ndc11
    8576602630
    30 TABLET, FILM COATED in 1 BOTTLE (85766-026-30)
  • ndc11
    8576602655
    1500 TABLET, FILM COATED in 1 BOTTLE (85766-026-55)
  • ndc11
    8576602660
    60 TABLET, FILM COATED in 1 BOTTLE (85766-026-60)
  • ndc11
    8576602690
    90 TABLET, FILM COATED in 1 BOTTLE (85766-026-90)

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": "85766-026_4a16992e-bbaa-c4b0-e063-6294a90af825",
  "productndc": "85766-026",
  "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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