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United States · US · US:58151-385_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 · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
N203109
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": {
"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": "58151-385_3fa2b889-ff04-4db1-b2c8-c0238efe240b",
"productndc": "58151-385",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "203109",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 10MG BASE/ML",
"product_no": "001",
"approval_date": "Aug 30, 2012"
}
],
"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": "NDA203109",
"marketing_category": "NDA",
"nonproprietary_name": "sildenafil citrate",
"start_marketing_date": "20241025",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code G04BE03.
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