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United States · US · US:71858-0205_4bb77632-4747-6bd7-e063-6294a90ae54e
Vybrique
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIBSA Pharma Inc.
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1171858020521 FILM in 1 POUCH (71858-0205-2)
- ndc1171858020541 FILM in 1 POUCH (71858-0205-4)
- ndc1171858020554 POUCH in 1 CARTON (71858-0205-5) / 1 FILM in 1 POUCH
- ndc1171858020568 POUCH in 1 CARTON (71858-0205-6) / 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": {
"9213fec1-e0c0-4ef7-9718-d97922a3f4d8": {
"match": "brand_token",
"title": "VYBRIQUE (SILDENAFIL CITRATE) FILM [IBSA PHARMA INC.]",
"spl_version": "8",
"published_date": "2026-02-27"
}
},
"productid": "71858-0205_4bb77632-4747-6bd7-e063-6294a90ae54e",
"productndc": "71858-0205",
"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": "Vybrique",
"active_ingred_unit": "mg/1",
"application_number": "NDA210858",
"marketing_category": "NDA",
"nonproprietary_name": "sildenafil citrate",
"start_marketing_date": "20260215",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code G04BE03.
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