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United States · US · US:63304-905_744b60c8-568b-4726-881c-68709c30f28a
Valacyclovir
Orange BookUNIISPLATC J05AB11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSUN PHARMACEUTICAL INDUSTRIES, INC.
CountryUS (United States)
ATC codeJ05AB11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11633049050310 TABLET, FILM COATED in 1 BOTTLE (63304-905-03)
- ndc116330490505500 TABLET, FILM COATED in 1 BOTTLE (63304-905-05)
- ndc11633049053030 TABLET, FILM COATED in 1 BOTTLE (63304-905-30)
- ndc116330490577100 BLISTER PACK in 1 CARTON (63304-905-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (63304-905-11)
- ndc11633049059090 TABLET, FILM COATED in 1 BOTTLE (63304-905-90)
Annotations
UNII (FDA Substance ID)
G447S0T1VC
VALACYCLOVIR HYDROCHLORIDE
RxCUI 236081
Orange Book
A076588
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": "63304-905_744b60c8-568b-4726-881c-68709c30f28a",
"productndc": "63304-905",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "076588",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 500MG BASE",
"product_no": "001",
"approval_date": "Jan 31, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1GM BASE",
"product_no": "002",
"approval_date": "Jan 31, 2007"
}
],
"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": "ANDA076588",
"marketing_category": "ANDA",
"nonproprietary_name": "Valacyclovir",
"start_marketing_date": "20201219",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code J05AB11.
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