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United States · US · US:70710-1716_b42790ec-b9ad-4b34-b98d-dfb8d246eff2
Sildenafil Citrate
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals (USA) Inc.
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1170710171641 BOTTLE, GLASS in 1 CARTON (70710-1716-4) / 112 mL in 1 BOTTLE, GLASS
- ndc1170710171651 BOTTLE, PLASTIC in 1 CARTON (70710-1716-5) / 112 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A215708
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": "70710-1716_b42790ec-b9ad-4b34-b98d-dfb8d246eff2",
"productndc": "70710-1716",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "215708",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE/ML",
"product_no": "001",
"approval_date": "Sep 29, 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": "ANDA215708",
"marketing_category": "ANDA",
"nonproprietary_name": "Sildenafil Citrate",
"start_marketing_date": "20221027",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code G04BE03.
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