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United States · US · US:69097-953_31499b53-d7e9-49e4-8eaa-c527c7403f9c
SILDENAFIL
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCIPLA USA INC.,
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11690979530230 TABLET in 1 BOTTLE (69097-953-02)
- ndc116909795307100 TABLET in 1 BOTTLE (69097-953-07)
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": "69097-953_31499b53-d7e9-49e4-8eaa-c527c7403f9c",
"productndc": "69097-953",
"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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