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United States · US · US:69238-1574_87224b5f-b3ee-40e4-8ac1-45356a1b86eb
Sildenafil
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169238157411 BOTTLE, GLASS in 1 CARTON (69238-1574-1) / 112 mL in 1 BOTTLE, GLASS
Annotations
UNII (FDA Substance ID)
3M7OB98Y7H
SILDENAFIL
RxCUI 136411
Orange Book
A211092
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "3M7OB98Y7H",
"rxcui": "136411",
"inchikey": "BNRNXUUZRGQAQC-UHFFFAOYSA-N",
"display_name": "SILDENAFIL",
"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": "69238-1574_87224b5f-b3ee-40e4-8ac1-45356a1b86eb",
"productndc": "69238-1574",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "211092",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE/ML",
"product_no": "001",
"approval_date": "Nov 27, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SILDENAFIL",
"proprietary_name": "Sildenafil",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA211092",
"marketing_category": "ANDA",
"nonproprietary_name": "Sildenafil",
"start_marketing_date": "20191206",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code G04BE03.
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