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United States · US · US:46708-235_2ca8929b-0b62-4302-9ab4-60ad3768e803
Vardenafil
Orange BookSPLATC G04BE09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeG04BE09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1146708235044 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (46708-235-04)
Annotations
Orange Book
A208324
AB
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": "46708-235_2ca8929b-0b62-4302-9ab4-60ad3768e803",
"productndc": "46708-235",
"dosage_form": "TABLET, ORALLY DISINTEGRATING",
"orange_book": {
"appl_no": "208324",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Nov 16, 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": "ANDA208324",
"marketing_category": "ANDA",
"nonproprietary_name": "Vardenafil",
"start_marketing_date": "20181120",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code G04BE09.
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