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United States · US · US:71610-903_351dae30-b57e-b988-e063-6394a90a47f2
TADALAFIL
Orange BookUNIISPLATC G04BE08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeG04BE08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1171610903044 TABLET in 1 BOTTLE (71610-903-04)
- ndc11716109031212 TABLET in 1 BOTTLE (71610-903-12)
- ndc117161090331600 TABLET in 1 BOTTLE (71610-903-31)
- ndc11716109035218 TABLET in 1 BOTTLE (71610-903-52)
Annotations
UNII (FDA Substance ID)
742SXX0ICT
TADALAFIL
RxCUI 358263
Orange Book
A210609
AB1AB1AB1AB1
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "742SXX0ICT",
"rxcui": "358263",
"inchikey": "WOXKDUGGOYFFRN-IIBYNOLFSA-N",
"display_name": "TADALAFIL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b3a58c17-f260-4125-abd1-27da00bb0719": {
"match": "brand_token",
"title": "TADALAFIL TABLET [BRYANT RANCH PREPACK]",
"spl_version": "102",
"published_date": "2026-06-01"
}
},
"productid": "71610-903_351dae30-b57e-b988-e063-6394a90a47f2",
"productndc": "71610-903",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "210609",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "Aug 11, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "5MG",
"product_no": "002",
"approval_date": "Aug 11, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "10MG",
"product_no": "003",
"approval_date": "Aug 11, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "20MG",
"product_no": "004",
"approval_date": "Aug 11, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TADALAFIL",
"proprietary_name": "TADALAFIL",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210609",
"marketing_category": "ANDA",
"nonproprietary_name": "tadalafil",
"start_marketing_date": "20220118",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code G04BE08.
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