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United States · US · US:63629-8409_df1f450c-40c6-499e-af71-b3300db4f62c
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
- ndc11636298409190 TABLET, FILM COATED in 1 BOTTLE (63629-8409-1)
- ndc11636298409230 TABLET, FILM COATED in 1 BOTTLE (63629-8409-2)
- ndc11636298409310 TABLET, FILM COATED in 1 BOTTLE (63629-8409-3)
- ndc11636298409420 TABLET, FILM COATED in 1 BOTTLE (63629-8409-4)
Annotations
UNII (FDA Substance ID)
742SXX0ICT
TADALAFIL
RxCUI 358263
Orange Book
A209167
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": "63629-8409_df1f450c-40c6-499e-af71-b3300db4f62c",
"productndc": "63629-8409",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "209167",
"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": "Oct 23, 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": "ANDA209167",
"marketing_category": "ANDA",
"nonproprietary_name": "Tadalafil",
"start_marketing_date": "20190327",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code G04BE08.
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