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United States · US · US:68788-8465_a2d04de6-0652-4040-9aa3-9575514262b8
TADALAFIL
Orange BookUNIISPLATC G04BE08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG04BE08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11687888465115 TABLET in 1 BOTTLE (68788-8465-1)
- ndc11687888465220 TABLET in 1 BOTTLE (68788-8465-2)
Annotations
UNII (FDA Substance ID)
742SXX0ICT
TADALAFIL
RxCUI 358263
Orange Book
A210609
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": "68788-8465_a2d04de6-0652-4040-9aa3-9575514262b8",
"productndc": "68788-8465",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "210609",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "Aug 11, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "5MG",
"product_no": "002",
"approval_date": "Aug 11, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "10MG",
"product_no": "003",
"approval_date": "Aug 11, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "20MG",
"product_no": "004",
"approval_date": "Aug 11, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TADALAFIL",
"proprietary_name": "TADALAFIL",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210609",
"marketing_category": "ANDA",
"nonproprietary_name": "tadalafil",
"start_marketing_date": "20230623",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code G04BE08.
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