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United States · US · US:43353-345_c1c88939-6766-4d48-bf65-c0662f1472e4
Sildenafil
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11433533451010 TABLET, FILM COATED in 1 BOTTLE (43353-345-10)
- ndc11433533452020 TABLET, FILM COATED in 1 BOTTLE (43353-345-20)
- ndc11433533455360 TABLET, FILM COATED in 1 BOTTLE (43353-345-53)
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
N021845
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "BW9B0ZE037",
"rxcui": "221161",
"inchikey": "DEIYFTQMQPDXOT-UHFFFAOYSA-N",
"display_name": "SILDENAFIL CITRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"78c4551c-b922-43c9-9a5a-66377ea07bc2": {
"match": "brand_token",
"title": "SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
"spl_version": "24",
"published_date": "2026-05-29"
}
},
"productid": "43353-345_c1c88939-6766-4d48-bf65-c0662f1472e4",
"productndc": "43353-345",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "021845",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Jun 3, 2005"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SILDENAFIL CITRATE",
"proprietary_name": "Sildenafil",
"active_ingred_unit": "mg/1",
"application_number": "NDA021845",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "sildenafil citrate",
"start_marketing_date": "20120927",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code G04BE03.
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