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United States · US · US:68382-899_5a958db7-5c0e-4cf0-9227-230886cf9bf8
Tadalafil
Orange BookUNIISPLATC G04BE08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeG04BE08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc116838289901100 TABLET, FILM COATED in 1 BOTTLE (68382-899-01)
- ndc116838289905500 TABLET, FILM COATED in 1 BOTTLE (68382-899-05)
- ndc11683828990630 TABLET, FILM COATED in 1 BOTTLE (68382-899-06)
- ndc1168382899101000 TABLET, FILM COATED in 1 BOTTLE (68382-899-10)
- ndc11683828991690 TABLET, FILM COATED in 1 BOTTLE (68382-899-16)
- ndc1168382899992 BLISTER PACK in 1 CARTON (68382-899-99) / 15 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
742SXX0ICT
TADALAFIL
RxCUI 358263
Orange Book
A206693
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": "68382-899_5a958db7-5c0e-4cf0-9227-230886cf9bf8",
"productndc": "68382-899",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "206693",
"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": "ANDA206693",
"marketing_category": "ANDA",
"nonproprietary_name": "Tadalafil",
"start_marketing_date": "20190327",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code G04BE08.
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