🇺🇸
United States · US · US:63629-8288_08531412-01c1-4053-93b6-83f785a873cd
Tadalafil
Orange BookUNIISPLATC G04BE08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeG04BE08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11636298288130 TABLET in 1 BOTTLE (63629-8288-1)
- ndc11636298288290 TABLET in 1 BOTTLE (63629-8288-2)
- ndc11636298288315 TABLET in 1 BOTTLE (63629-8288-3)
- ndc11636298288460 TABLET in 1 BOTTLE (63629-8288-4)
Annotations
UNII (FDA Substance ID)
742SXX0ICT
TADALAFIL
RxCUI 358263
Orange Book
A209654
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": "63629-8288_08531412-01c1-4053-93b6-83f785a873cd",
"productndc": "63629-8288",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209654",
"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": "ANDA209654",
"marketing_category": "ANDA",
"nonproprietary_name": "Tadalafil",
"start_marketing_date": "20190326",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code G04BE08.
Access this data programmatically
Query Tadalafil 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.