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United States · US · US:63187-789_ab4d1c94-4535-4233-8521-6ec8059b7a05
Sildenafil
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc11631877891010 TABLET in 1 BOTTLE (63187-789-10)
- ndc11631877892020 TABLET in 1 BOTTLE (63187-789-20)
- ndc11631877893030 TABLET in 1 BOTTLE (63187-789-30)
- ndc11631877895050 TABLET in 1 BOTTLE (63187-789-50)
- ndc11631877896060 TABLET in 1 BOTTLE (63187-789-60)
- ndc11631877899090 TABLET in 1 BOTTLE (63187-789-90)
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": "63187-789_ab4d1c94-4535-4233-8521-6ec8059b7a05",
"productndc": "63187-789",
"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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