Valacyclovir hydrochloride

Orange BookUNIISPLATC J05AB11

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.

CountryUS (United States)

ATC codeJ05AB11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6878868961
10 TABLET in 1 BOTTLE (68788-6896-1)
ndc11
6878868962
20 TABLET in 1 BOTTLE (68788-6896-2)
ndc11
6878868963
30 TABLET in 1 BOTTLE (68788-6896-3)
ndc11
6878868964
4 TABLET in 1 BOTTLE (68788-6896-4)
ndc11
6878868966
6 TABLET in 1 BOTTLE (68788-6896-6)
ndc11
6878868967
21 TABLET in 1 BOTTLE (68788-6896-7)

Annotations

UNII (FDA Substance ID)

G447S0T1VC

VALACYCLOVIR HYDROCHLORIDE

RxCUI 236081

Orange Book

A077135

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": "68788-6896_7c60d1d2-a924-4118-9d74-b5c5d0c4d0a9",
  "productndc": "68788-6896",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077135",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 500MG BASE",
        "product_no": "001",
        "approval_date": "May 24, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "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": "ANDA077135",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Valacyclovir hydrochloride",
  "start_marketing_date": "20170213",
  "active_numerator_strength": "500"
}

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