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United States · US · US:70518-4100_4c9a1905-a99c-3ba5-e063-6394a90ab5bb
Valacyclovir
Orange BookUNIISPLATC J05AB11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeJ05AB11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc11705184100030 TABLET in 1 BOTTLE, PLASTIC (70518-4100-0)
- ndc11705184100214 TABLET in 1 BOTTLE, PLASTIC (70518-4100-2)
- ndc1170518410037 TABLET in 1 BOTTLE, PLASTIC (70518-4100-3)
- ndc1170518410044 TABLET in 1 BOTTLE, PLASTIC (70518-4100-4)
- ndc11705184100510 TABLET in 1 BOTTLE, PLASTIC (70518-4100-5)
- ndc11705184100620 TABLET in 1 BOTTLE, PLASTIC (70518-4100-6)
Annotations
UNII (FDA Substance ID)
G447S0T1VC
VALACYCLOVIR HYDROCHLORIDE
RxCUI 236081
Orange Book
A209553
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": "70518-4100_4c9a1905-a99c-3ba5-e063-6394a90ab5bb",
"productndc": "70518-4100",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209553",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 500MG BASE",
"product_no": "001",
"approval_date": "Mar 18, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1GM BASE",
"product_no": "002",
"approval_date": "Mar 18, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VALACYCLOVIR HYDROCHLORIDE",
"proprietary_name": "Valacyclovir",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209553",
"marketing_category": "ANDA",
"nonproprietary_name": "Valacyclovir",
"start_marketing_date": "20240612",
"active_numerator_strength": "1000"
}Related drugs
Other records sharing ATC code J05AB11.
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