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United States · US · US:65862-688_aee36818-4865-49b7-9f54-29c62f8d4fda
Sildenafil
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11658626889090 TABLET, FILM COATED in 1 BOTTLE (65862-688-90)
- ndc1165862688991000 TABLET, FILM COATED in 1 BOTTLE (65862-688-99)
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A203963
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": "65862-688_aee36818-4865-49b7-9f54-29c62f8d4fda",
"productndc": "65862-688",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "203963",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Nov 18, 2015"
}
],
"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": "ANDA203963",
"marketing_category": "ANDA",
"nonproprietary_name": "Sildenafil",
"start_marketing_date": "20151118",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code G04BE03.
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