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United States · US · US:71205-473_1d2a3b34-3e71-4a4b-81ed-4ff35976abc0
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 · 5
- ndc11712054731010 TABLET in 1 BOTTLE (71205-473-10)
- ndc11712054732020 TABLET in 1 BOTTLE (71205-473-20)
- ndc11712054733030 TABLET in 1 BOTTLE (71205-473-30)
- ndc11712054736060 TABLET in 1 BOTTLE (71205-473-60)
- ndc11712054739090 TABLET in 1 BOTTLE (71205-473-90)
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A207178
ABABAB
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": "71205-473_1d2a3b34-3e71-4a4b-81ed-4ff35976abc0",
"productndc": "71205-473",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "207178",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Mar 2, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "002",
"approval_date": "Mar 2, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "003",
"approval_date": "Mar 2, 2020"
}
],
"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": "ANDA207178",
"marketing_category": "ANDA",
"nonproprietary_name": "SILDENAFIL",
"start_marketing_date": "20200710",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code G04BE03.
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