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United States · US · US:33342-152_b02d220c-5dd4-4557-880a-7d4c0d8927b9
Vardenafil Hydrochloride
Orange BookUNIISPLATC 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 · 3
- ndc11333421520730 TABLET in 1 BOTTLE (33342-152-07)
- ndc113334215211100 TABLET in 1 BOTTLE (33342-152-11)
- ndc11333421521210 BLISTER PACK in 1 CARTON (33342-152-12) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
UCE6F4125H
VARDENAFIL
RxCUI 306674
Orange Book
A204632
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "UCE6F4125H",
"rxcui": "306674",
"inchikey": "SECKRCOLJRRGGV-UHFFFAOYSA-N",
"display_name": "VARDENAFIL",
"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": "33342-152_b02d220c-5dd4-4557-880a-7d4c0d8927b9",
"productndc": "33342-152",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "204632",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2.5MG BASE",
"product_no": "001",
"approval_date": "Oct 22, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "Oct 22, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "003",
"approval_date": "Oct 22, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "004",
"approval_date": "Oct 22, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VARDENAFIL",
"proprietary_name": "Vardenafil Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204632",
"marketing_category": "ANDA",
"nonproprietary_name": "Vardenafil Hydrochloride",
"start_marketing_date": "20191024",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code G04BE09.
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