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United States · US · US:59762-0035_6b8ead94-5df8-4fbd-a75e-388f8147fe5d
Sildenafil Citrate
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11597620035130 TABLET, FILM COATED in 1 BOTTLE (59762-0035-1)
- ndc115976200352100 TABLET, FILM COATED in 1 BOTTLE (59762-0035-2)
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
N020895
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": "59762-0035_6b8ead94-5df8-4fbd-a75e-388f8147fe5d",
"productndc": "59762-0035",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "020895",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Mar 27, 1998"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "002",
"approval_date": "Mar 27, 1998"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "003",
"approval_date": "Mar 27, 1998"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SILDENAFIL CITRATE",
"proprietary_name": "Sildenafil Citrate",
"active_ingred_unit": "mg/1",
"application_number": "NDA020895",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "sildenafil citrate",
"start_marketing_date": "20171201",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code G04BE03.
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