🇺🇸
United States · US · US:68788-8804_5846bff2-6a93-46a7-a547-04459c590814
SILDENAFIL CITRATE
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11687888804110 TABLET in 1 BOTTLE (68788-8804-1)
- ndc11687888804330 TABLET in 1 BOTTLE (68788-8804-3)
- ndc1168788880477 TABLET in 1 BOTTLE (68788-8804-7)
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A209302
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": "68788-8804_5846bff2-6a93-46a7-a547-04459c590814",
"productndc": "68788-8804",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209302",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "001",
"approval_date": "Aug 25, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "002",
"approval_date": "Aug 25, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "003",
"approval_date": "Jun 15, 2021"
}
],
"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": "ANDA209302",
"marketing_category": "ANDA",
"nonproprietary_name": "SILDENAFIL CITRATE",
"start_marketing_date": "20250120",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code G04BE03.
Access this data programmatically
Query SILDENAFIL CITRATE 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.