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United States · US · US:70954-168_7e36fae8-7fbe-44fe-a951-66f18f1b3fe1
Sildenafil
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170954168101 BOTTLE in 1 CARTON (70954-168-10) / 112 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A212260
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": "70954-168_7e36fae8-7fbe-44fe-a951-66f18f1b3fe1",
"productndc": "70954-168",
"dosage_form": "FOR SUSPENSION",
"orange_book": {
"appl_no": "212260",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE/ML",
"product_no": "001",
"approval_date": "May 31, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SILDENAFIL CITRATE",
"proprietary_name": "Sildenafil",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA212260",
"marketing_category": "ANDA",
"nonproprietary_name": "Sildenafil citrate",
"start_marketing_date": "20190531",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code G04BE03.
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