🇺🇸
United States · US · US:58151-395_3fa2b889-ff04-4db1-b2c8-c0238efe240b
Revatio
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1158151395311 VIAL in 1 CARTON (58151-395-31) / 12.5 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
N022473
AP
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": "INTRAVENOUS",
"spl_meta": {
"f158fe10-d5dc-4432-b2c9-fc665401291b": {
"match": "brand_token",
"title": "REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]",
"spl_version": "45",
"published_date": "2025-06-09"
}
},
"productid": "58151-395_3fa2b889-ff04-4db1-b2c8-c0238efe240b",
"productndc": "58151-395",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "022473",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)",
"product_no": "001",
"approval_date": "Nov 18, 2009"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SILDENAFIL CITRATE",
"proprietary_name": "Revatio",
"active_ingred_unit": "mg/mL",
"application_number": "NDA022473",
"marketing_category": "NDA",
"nonproprietary_name": "sildenafil citrate",
"start_marketing_date": "20250409",
"active_numerator_strength": ".8"
}Related drugs
Other records sharing ATC code G04BE03.
Access this data programmatically
Query Revatio 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.