valacyclovir hydrochloride

Orange BookUNIISPLATC J05AB11

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

Identification

ManufacturerJubilant Cadista Pharmaceuticals Inc.

CountryUS (United States)

ATC codeJ05AB11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
5974632501
100 TABLET, FILM COATED in 1 BOTTLE (59746-325-01)
ndc11
5974632510
10 TABLET, FILM COATED in 1 BOTTLE (59746-325-10)
ndc11
5974632530
30 TABLET, FILM COATED in 1 BOTTLE (59746-325-30)
ndc11
5974632537
250 TABLET, FILM COATED in 1 BOTTLE (59746-325-37)
ndc11
5974632547
300 TABLET, FILM COATED in 1 BOTTLE (59746-325-47)
ndc11
5974632590
90 TABLET, FILM COATED in 1 BOTTLE (59746-325-90)

Annotations

UNII (FDA Substance ID)

G447S0T1VC

VALACYCLOVIR HYDROCHLORIDE

RxCUI 236081

Orange Book

A201506

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": "59746-325_40211dd2-c21e-45a4-a8d4-04febf925f52",
  "productndc": "59746-325",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "201506",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "001",
        "approval_date": "Apr 3, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1GM BASE",
        "product_no": "002",
        "approval_date": "Apr 3, 2012"
      }
    ],
    "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": "ANDA201506",
  "marketing_category": "ANDA",
  "nonproprietary_name": "valacyclovir hydrochloride",
  "start_marketing_date": "20120405",
  "active_numerator_strength": "1"
}

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