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
5974632401
100 TABLET, FILM COATED in 1 BOTTLE (59746-324-01)
ndc11
5974632410
10 TABLET, FILM COATED in 1 BOTTLE (59746-324-10)
ndc11
5974632430
30 TABLET, FILM COATED in 1 BOTTLE (59746-324-30)
ndc11
5974632437
250 TABLET, FILM COATED in 1 BOTTLE (59746-324-37)
ndc11
5974632447
300 TABLET, FILM COATED in 1 BOTTLE (59746-324-47)
ndc11
5974632490
90 TABLET, FILM COATED in 1 BOTTLE (59746-324-90)

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": "59746-324_40211dd2-c21e-45a4-a8d4-04febf925f52",
  "productndc": "59746-324",
  "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": "mg/1",
  "application_number": "ANDA201506",
  "marketing_category": "ANDA",
  "nonproprietary_name": "valacyclovir hydrochloride",
  "start_marketing_date": "20120405",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code J05AB11.

Access this data programmatically

Query valacyclovir hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs