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United States · US · US:55150-166_c6f23ad9-ca87-47a3-8d85-dfc334e5a91b
Sildenafil
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEugia US LLC
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1155150166131 VIAL, SINGLE-DOSE in 1 CARTON (55150-166-13) / 12.5 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A203988
AP
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": "INTRAVENOUS",
"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": "55150-166_c6f23ad9-ca87-47a3-8d85-dfc334e5a91b",
"productndc": "55150-166",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "203988",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)",
"product_no": "001",
"approval_date": "Apr 1, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SILDENAFIL CITRATE",
"proprietary_name": "Sildenafil",
"active_ingred_unit": "mg/12.5mL",
"application_number": "ANDA203988",
"marketing_category": "ANDA",
"nonproprietary_name": "Sildenafil Citrate",
"start_marketing_date": "20150401",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code G04BE03.
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