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United States · US · US:60290-079_51b76a30-43fd-eaa4-e063-6394a90a286d
SILDENAFIL CITRATE
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUmedica Laboratories USA Inc.
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11602900790130 TABLET, FILM COATED in 1 BOTTLE (60290-079-01)
- ndc11602900790290 TABLET, FILM COATED in 1 BOTTLE (60290-079-02)
- ndc1160290079031000 TABLET, FILM COATED in 1 BOTTLE (60290-079-03)
- ndc116029007904500 TABLET, FILM COATED in 1 BOTTLE (60290-079-04)
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A209302
ABABAB
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": "60290-079_51b76a30-43fd-eaa4-e063-6394a90a286d",
"productndc": "60290-079",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "209302",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "001",
"approval_date": "Aug 25, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "002",
"approval_date": "Aug 25, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "003",
"approval_date": "Jun 15, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SILDENAFIL CITRATE",
"proprietary_name": "SILDENAFIL CITRATE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209302",
"marketing_category": "ANDA",
"nonproprietary_name": "SILDENAFIL CITRATE",
"start_marketing_date": "20260215",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code G04BE03.
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