🇺🇸
United States · US · US:33342-041_e89d523d-8d42-4bbf-be3d-2b15e7c15f4f
Sildenafil
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11333420410730 TABLET, FILM COATED in 1 BOTTLE (33342-041-07)
- ndc113334204111100 TABLET, FILM COATED in 1 BOTTLE (33342-041-11)
- ndc1133342041441000 TABLET, FILM COATED in 1 BOTTLE (33342-041-44)
- ndc1133342041981 BLISTER PACK in 1 CARTON (33342-041-98) / 60 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A202255
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": "33342-041_e89d523d-8d42-4bbf-be3d-2b15e7c15f4f",
"productndc": "33342-041",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202255",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Apr 19, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "002",
"approval_date": "Apr 19, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "003",
"approval_date": "Apr 19, 2023"
}
],
"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": "ANDA202255",
"marketing_category": "ANDA",
"nonproprietary_name": "Sildenafil",
"start_marketing_date": "20230419",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code G04BE03.
Access this data programmatically
Query Sildenafil and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.