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United States · US · US:71610-477_9d2796f2-b596-4588-96c8-f99407d3e671
VARDENAFIL
Orange BookSPLATC 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 · 4
- ndc1171610477022 TABLET, FILM COATED in 1 BOTTLE (71610-477-02)
- ndc1171610477044 TABLET, FILM COATED in 1 BOTTLE (71610-477-04)
- ndc1171610477066 TABLET, FILM COATED in 1 BOTTLE (71610-477-06)
- ndc11716104771212 TABLET, FILM COATED in 1 BOTTLE (71610-477-12)
Annotations
Orange Book
A208960
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"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": "71610-477_9d2796f2-b596-4588-96c8-f99407d3e671",
"productndc": "71610-477",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208960",
"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": true,
"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 TRIHYDRATE",
"proprietary_name": "VARDENAFIL",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208960",
"marketing_category": "ANDA",
"nonproprietary_name": "VARDENAFIL",
"start_marketing_date": "20181101",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code G04BE09.
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