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United States · US · US:65162-351_fcdd909b-5c4f-4055-8a2a-61c672d68994
Sildenafil
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11651623510990 TABLET in 1 BOTTLE (65162-351-09)
- ndc1165162351111000 TABLET in 1 BOTTLE (65162-351-11)
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A202025
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": "65162-351_fcdd909b-5c4f-4055-8a2a-61c672d68994",
"productndc": "65162-351",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "202025",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Feb 28, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SILDENAFIL CITRATE",
"proprietary_name": "Sildenafil",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202025",
"marketing_category": "ANDA",
"nonproprietary_name": "Sildenafil",
"start_marketing_date": "20121108",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code G04BE03.
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