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United States · US · US:46708-180_53d81162-1774-48a1-b19b-f2b0e2d1020a
Tadalafil
Orange BookUNIISPLATC G04BE08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeG04BE08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11467081803030 TABLET, COATED in 1 BOTTLE (46708-180-30)
- ndc114670818071500 TABLET, COATED in 1 BOTTLE (46708-180-71)
- ndc1146708180911000 TABLET, COATED in 1 BOTTLE (46708-180-91)
Annotations
UNII (FDA Substance ID)
742SXX0ICT
TADALAFIL
RxCUI 358263
Orange Book
A204809
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": "46708-180_53d81162-1774-48a1-b19b-f2b0e2d1020a",
"productndc": "46708-180",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "204809",
"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": "ANDA204809",
"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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