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United States · US · US:76420-564_fb50d332-1618-2b63-e053-6394a90ad585
Sildenafil Citrate
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc117642056401100 TABLET, FILM COATED in 1 BOTTLE (76420-564-01)
- ndc11764205643030 TABLET, FILM COATED in 1 BOTTLE (76420-564-30)
- ndc11764205646060 TABLET, FILM COATED in 1 BOTTLE (76420-564-60)
- ndc11764205649090 TABLET, FILM COATED in 1 BOTTLE (76420-564-90)
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A206401
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": "76420-564_fb50d332-1618-2b63-e053-6394a90ad585",
"productndc": "76420-564",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "206401",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Oct 12, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "002",
"approval_date": "Oct 12, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "003",
"approval_date": "Oct 12, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SILDENAFIL CITRATE",
"proprietary_name": "Sildenafil Citrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206401",
"marketing_category": "ANDA",
"nonproprietary_name": "Sildenafil",
"start_marketing_date": "20181012",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code G04BE03.
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