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United States · US · US:67046-1347_5100e0ed-43ff-f8a5-e063-6294a90a8d75
Valacyclovir
Orange BookUNIISPLATC J05AB11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCoupler LLC
CountryUS (United States)
ATC codeJ05AB11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11670461347330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1347-3)
Annotations
UNII (FDA Substance ID)
G447S0T1VC
VALACYCLOVIR HYDROCHLORIDE
RxCUI 236081
Orange Book
A203047
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": "67046-1347_5100e0ed-43ff-f8a5-e063-6294a90a8d75",
"productndc": "67046-1347",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "203047",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 500MG BASE",
"product_no": "001",
"approval_date": "Apr 8, 2015"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 1GM BASE",
"product_no": "002",
"approval_date": "Apr 8, 2015"
}
],
"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": "ANDA203047",
"marketing_category": "ANDA",
"nonproprietary_name": "Valacyclovir",
"start_marketing_date": "20260504",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code J05AB11.
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