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United States · US · US:70518-2039_499baba0-82b1-4029-e063-6294a90a0297
VALTREX
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 · 2
- ndc11705182039114 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2039-1)
- ndc1170518203925 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2039-2)
Annotations
UNII (FDA Substance ID)
G447S0T1VC
VALACYCLOVIR HYDROCHLORIDE
RxCUI 236081
Orange Book
N020487
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": {
"56a62c21-bead-4f3b-a24e-c3fd0b4a732f": {
"match": "brand_token",
"title": "VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC.]",
"spl_version": "14",
"published_date": "2026-02-02"
}
},
"productid": "70518-2039_499baba0-82b1-4029-e063-6294a90a0297",
"productndc": "70518-2039",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "020487",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 500MG BASE",
"product_no": "001",
"approval_date": "Jun 23, 1995"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 1GM BASE",
"product_no": "002",
"approval_date": "Jun 23, 1995"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VALACYCLOVIR HYDROCHLORIDE",
"proprietary_name": "VALTREX",
"active_ingred_unit": "g/1",
"application_number": "NDA020487",
"marketing_category": "NDA",
"nonproprietary_name": "valacyclovir hydrochloride",
"start_marketing_date": "20190426",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code J05AB11.
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