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United States · US · US:13668-185_8b584f5d-8030-4f91-a129-8120f9e1b204
Sildenafil
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTorrent Pharmaceuticals Limited
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc111366818505500 TABLET, FILM COATED in 1 BOTTLE (13668-185-05)
- ndc1113668185101000 TABLET, FILM COATED in 1 BOTTLE (13668-185-10)
- ndc11136681853030 TABLET, FILM COATED in 1 BOTTLE (13668-185-30)
- ndc1113668185515000 TABLET, FILM COATED in 1 BOTTLE (13668-185-51)
- ndc11136681859090 TABLET, FILM COATED in 1 BOTTLE (13668-185-90)
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A091479
AB
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": "13668-185_8b584f5d-8030-4f91-a129-8120f9e1b204",
"productndc": "13668-185",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "091479",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Nov 6, 2012"
}
],
"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": "ANDA091479",
"marketing_category": "ANDA",
"nonproprietary_name": "Sildenafil",
"start_marketing_date": "20121106",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code G04BE03.
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