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United States · US · US:33342-203_695d5a7e-546f-4e86-8edc-3c32e1d3bb19
Vardenafil
Orange BookSPLATC G04BE09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeG04BE09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1133342203371 BLISTER PACK in 1 CARTON (33342-203-37) / 4 TABLET in 1 BLISTER PACK
Annotations
Orange Book
A205988
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": "33342-203_695d5a7e-546f-4e86-8edc-3c32e1d3bb19",
"productndc": "33342-203",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "205988",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Mar 10, 2020"
}
],
"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": "ANDA205988",
"marketing_category": "ANDA",
"nonproprietary_name": "Vardenafil",
"start_marketing_date": "20181026",
"active_numerator_strength": "11.85"
}Related drugs
Other records sharing ATC code G04BE09.
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