Valacyclovir Hydrochloride

Orange BookUNIISPLATC J05AB11

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

Identification

ManufacturerTIME CAP LABORATORIES, INC.

CountryUS (United States)

ATC codeJ05AB11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4948369101
100 TABLET in 1 BOTTLE (49483-691-01)
ndc11
4948369103
30 TABLET in 1 BOTTLE (49483-691-03)
ndc11
4948369104
10 TABLET in 1 BLISTER PACK (49483-691-04)
ndc11
4948369150
500 TABLET in 1 BOTTLE (49483-691-50)

Annotations

UNII (FDA Substance ID)

G447S0T1VC

VALACYCLOVIR HYDROCHLORIDE

RxCUI 236081

Orange Book

A079012

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": "49483-691_c715d9f2-9fe1-0bdd-e053-2a95a90aecf2",
  "productndc": "49483-691",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "079012",
    "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": "ANDA079012",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Valacyclovir Hydrochloride",
  "start_marketing_date": "20210714",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code J05AB11.

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