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United States · US · US:59651-420_39509319-16be-4fc4-a60a-48ea8e9333c6
sildenafil CITRATE
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159651420111 BOTTLE in 1 CARTON (59651-420-11) / 112 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A214773
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": {
"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": "59651-420_39509319-16be-4fc4-a60a-48ea8e9333c6",
"productndc": "59651-420",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "214773",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE/ML",
"product_no": "001",
"approval_date": "Dec 23, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SILDENAFIL CITRATE",
"proprietary_name": "sildenafil CITRATE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA214773",
"marketing_category": "ANDA",
"nonproprietary_name": "sildenafil CITRATE",
"start_marketing_date": "20221223",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code G04BE03.
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