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United States · US · US:0069-4190_92557457-d941-4560-bfb1-1284d8902907
Revatio
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPFIZER LABORATORIES DIV PFIZER INC
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11006941906890 TABLET, FILM COATED in 1 BOTTLE (0069-4190-68)
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
N021845
AB
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": "0069-4190_92557457-d941-4560-bfb1-1284d8902907",
"productndc": "0069-4190",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "021845",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Jun 3, 2005"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SILDENAFIL CITRATE",
"proprietary_name": "Revatio",
"active_ingred_unit": "mg/1",
"application_number": "NDA021845",
"marketing_category": "NDA",
"nonproprietary_name": "sildenafil citrate",
"start_marketing_date": "20050603",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code G04BE03.
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