🇺🇸
United States · US · US:68180-283_18727593-f734-4bd5-88eb-625779d35660
SILDENAFIL
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168180283011 BOTTLE in 1 CARTON (68180-283-01) / 112 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A211638
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": "68180-283_18727593-f734-4bd5-88eb-625779d35660",
"productndc": "68180-283",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "211638",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 10MG BASE/ML",
"product_no": "001",
"approval_date": "Mar 23, 2022"
}
],
"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": "ANDA211638",
"marketing_category": "ANDA",
"nonproprietary_name": "Sildenafil",
"start_marketing_date": "20220928",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code G04BE03.
Access this data programmatically
Query SILDENAFIL and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.