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United States · US · US:70710-1070_a6417d62-c65a-49a5-a3c7-d9d178a36cb9
VARDENAFIL
Orange BookSPLATC G04BE09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeG04BE09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117071010701100 TABLET, FILM COATED in 1 BOTTLE (70710-1070-1)
- ndc11707101070330 TABLET, FILM COATED in 1 BOTTLE (70710-1070-3)
- ndc11707101070990 TABLET, FILM COATED in 1 BOTTLE (70710-1070-9)
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": "70710-1070_a6417d62-c65a-49a5-a3c7-d9d178a36cb9",
"productndc": "70710-1070",
"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": "10"
}Related drugs
Other records sharing ATC code G04BE09.
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