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United States · US · US:60290-027_50582108-5bae-7795-e063-6294a90aa191
Tadalafil
Orange BookUNIISPLATC G04BE08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUmedica Laboratories USA Inc.
CountryUS (United States)
ATC codeG04BE08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11602900270130 TABLET, FILM COATED in 1 BOTTLE (60290-027-01)
- ndc1160290027021000 TABLET, FILM COATED in 1 BOTTLE (60290-027-02)
- ndc11602900270330 TABLET, FILM COATED in 1 BLISTER PACK (60290-027-03)
- ndc116029002704500 TABLET, FILM COATED in 1 BOTTLE (60290-027-04)
Annotations
UNII (FDA Substance ID)
742SXX0ICT
TADALAFIL
RxCUI 358263
Orange Book
A211298
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": "60290-027_50582108-5bae-7795-e063-6294a90aa191",
"productndc": "60290-027",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211298",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "Oct 23, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "5MG",
"product_no": "002",
"approval_date": "Oct 23, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "10MG",
"product_no": "003",
"approval_date": "Oct 23, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "20MG",
"product_no": "004",
"approval_date": "Oct 23, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TADALAFIL",
"proprietary_name": "Tadalafil",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211298",
"marketing_category": "ANDA",
"nonproprietary_name": "Tadalafil",
"start_marketing_date": "20260215",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code G04BE08.
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