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United States · US · US:71610-508_56a14d26-0c09-4a32-bec0-d4fba1003548
Vardenafil Hydrochloride
Orange BookUNIISPLATC G04BE09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeG04BE09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1171610508022 TABLET in 1 BOTTLE (71610-508-02)
- ndc1171610508044 TABLET in 1 BOTTLE (71610-508-04)
- ndc11716105081212 TABLET in 1 BOTTLE (71610-508-12)
Annotations
UNII (FDA Substance ID)
5M8S2CU0TS
VARDENAFIL HYDROCHLORIDE
RxCUI 307306
Orange Book
A209057
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5M8S2CU0TS",
"rxcui": "307306",
"inchikey": "FBCDRHDULQYRTB-UHFFFAOYSA-N",
"display_name": "VARDENAFIL HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"80c4793d-e19e-10f0-e053-2991aa0a4620": {
"match": "brand_token",
"title": "VARDENAFIL HYDROCHLORIDE TABLET [AVKARE]",
"spl_version": "5",
"published_date": "2026-01-16"
}
},
"productid": "71610-508_56a14d26-0c09-4a32-bec0-d4fba1003548",
"productndc": "71610-508",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209057",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2.5MG BASE",
"product_no": "001",
"approval_date": "Oct 31, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "Oct 31, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "003",
"approval_date": "Oct 31, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "004",
"approval_date": "Oct 31, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VARDENAFIL HYDROCHLORIDE",
"proprietary_name": "Vardenafil Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209057",
"marketing_category": "ANDA",
"nonproprietary_name": "Vardenafil Hydrochloride",
"start_marketing_date": "20181101",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code G04BE09.
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