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United States · US · US:13668-187_e835d1de-642e-4ea7-98ff-390effd8331f
SILDENAFIL CITRATE
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
- ndc111366818701100 TABLET, FILM COATED in 1 BOTTLE (13668-187-01)
- ndc111366818705500 TABLET, FILM COATED in 1 BOTTLE (13668-187-05)
- ndc1113668187101000 TABLET, FILM COATED in 1 BOTTLE (13668-187-10)
- ndc1113668187181800 TABLET, FILM COATED in 1 BOTTLE (13668-187-18)
- ndc11136681873030 TABLET, FILM COATED in 1 BOTTLE (13668-187-30)
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A091448
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": "13668-187_e835d1de-642e-4ea7-98ff-390effd8331f",
"productndc": "13668-187",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "091448",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Jun 11, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "002",
"approval_date": "Jun 11, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "003",
"approval_date": "Jun 11, 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": "ANDA091448",
"marketing_category": "ANDA",
"nonproprietary_name": "SILDENAFIL",
"start_marketing_date": "20180611",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code G04BE03.
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