Valacyclovir

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 · 7

ndc11
6878875870
6 TABLET, FILM COATED in 1 BOTTLE (68788-7587-0)
ndc11
6878875871
10 TABLET, FILM COATED in 1 BOTTLE (68788-7587-1)
ndc11
6878875872
20 TABLET, FILM COATED in 1 BOTTLE (68788-7587-2)
ndc11
6878875873
30 TABLET, FILM COATED in 1 BOTTLE (68788-7587-3)
ndc11
6878875874
4 TABLET, FILM COATED in 1 BOTTLE (68788-7587-4)
ndc11
6878875875
15 TABLET, FILM COATED in 1 BOTTLE (68788-7587-5)
ndc11
6878875877
21 TABLET, FILM COATED in 1 BOTTLE (68788-7587-7)

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": "68788-7587_c347cba6-fba8-4c16-9584-c79d6c2a8179",
  "productndc": "68788-7587",
  "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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