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United States · US · US:69097-526_f5c8b23e-51e5-4264-8328-437c9d11939a
Tadalafil
Orange BookUNIISPLATC G04BE08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeG04BE08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11690975260360 TABLET, FILM COATED in 1 BOTTLE (69097-526-03)
- ndc1169097526164 TABLET, FILM COATED in 1 CARTON (69097-526-16)
Annotations
UNII (FDA Substance ID)
742SXX0ICT
TADALAFIL
RxCUI 358263
Orange Book
A210255
AB2
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": "69097-526_f5c8b23e-51e5-4264-8328-437c9d11939a",
"productndc": "69097-526",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "210255",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "20MG",
"product_no": "001",
"approval_date": "Feb 5, 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": "ANDA210255",
"marketing_category": "ANDA",
"nonproprietary_name": "Tadalafil",
"start_marketing_date": "20190205",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code G04BE08.
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