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United States · US · US:13668-581_1f85153f-5d3a-40d8-8570-1d969f4efa3c
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
- ndc11136685813030 TABLET in 1 BOTTLE (13668-581-30)
- ndc11136685816060 TABLET in 1 BOTTLE (13668-581-60)
Annotations
UNII (FDA Substance ID)
742SXX0ICT
TADALAFIL
RxCUI 358263
Orange Book
A212062
AB2
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": "13668-581_1f85153f-5d3a-40d8-8570-1d969f4efa3c",
"productndc": "13668-581",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "212062",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "20MG",
"product_no": "001",
"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": "ANDA212062",
"marketing_category": "ANDA",
"nonproprietary_name": "TADALAFIL",
"start_marketing_date": "20190326",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code G04BE08.
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