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United States · US · US:13668-566_8d94d098-d4f5-488c-8cc9-d21f32b727ec
TADALAFIL
Orange BookUNIISPLATC G04BE08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTorrent Pharmaceuticals Limited
CountryUS (United States)
ATC codeG04BE08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc111366856605500 TABLET in 1 BOTTLE (13668-566-05)
- ndc11136685663030 TABLET in 1 BOTTLE (13668-566-30)
Annotations
UNII (FDA Substance ID)
742SXX0ICT
TADALAFIL
RxCUI 358263
Orange Book
A211839
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": "13668-566_8d94d098-d4f5-488c-8cc9-d21f32b727ec",
"productndc": "13668-566",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211839",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "Mar 26, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "5MG",
"product_no": "002",
"approval_date": "Mar 26, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "10MG",
"product_no": "003",
"approval_date": "Mar 26, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "20MG",
"product_no": "004",
"approval_date": "Mar 26, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TADALAFIL",
"proprietary_name": "TADALAFIL",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211839",
"marketing_category": "ANDA",
"nonproprietary_name": "TADALAFIL",
"start_marketing_date": "20190326",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code G04BE08.
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