🇺🇸
United States · US · US:82347-0210_4ff9c8e2-7cb2-aedf-e063-6294a90a0b90
Sildenafil
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerYaral Pharma Inc.
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1182347021041 FILM in 1 POUCH (82347-0210-4)
- ndc1182347021054 POUCH in 1 CARTON (82347-0210-5) / 1 FILM in 1 POUCH
- ndc1182347021068 POUCH in 1 CARTON (82347-0210-6) / 1 FILM in 1 POUCH
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
N210858
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": "82347-0210_4ff9c8e2-7cb2-aedf-e063-6294a90a0b90",
"productndc": "82347-0210",
"dosage_form": "FILM",
"orange_book": {
"appl_no": "210858",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Dec 16, 2025"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 50MG BASE",
"product_no": "002",
"approval_date": "Dec 16, 2025"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 75MG BASE",
"product_no": "003",
"approval_date": "Dec 16, 2025"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 100MG BASE",
"product_no": "004",
"approval_date": "Dec 16, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SILDENAFIL CITRATE",
"proprietary_name": "Sildenafil",
"active_ingred_unit": "mg/1",
"application_number": "NDA210858",
"marketing_category": "NDA",
"nonproprietary_name": "sildenafil citrate",
"start_marketing_date": "20260215",
"active_numerator_strength": "50"
}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.