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United States · US · US:35561-257_49fc9e85-3dc2-064f-e063-6294a90af582
N/A
Orange BookUNIISPLATC G04BE08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBostal LLC
CountryUS (United States)
ATC codeG04BE08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11355612571030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-257-10)
- ndc113556125713500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-257-13)
Annotations
UNII (FDA Substance ID)
742SXX0ICT
TADALAFIL
RxCUI 358263
Orange Book
A208824
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": {
"4a4fa6e8-0e0a-0e76-e054-00144ff8d46c": {
"match": "brand_token",
"title": "N/A (ATROPINE SULFATE INJECTION USP, 1 MG/0.7 ML) INJECTION N/A (ATROPINE SULFATE INJECTION USP, 0.5 MG/0.7 ML) INJECTION N/A (ATROPINE INJECTION, 2 MG) INJECTION [RAFA LABORATORIES, LTD.]",
"spl_version": "8",
"published_date": "2026-02-19"
}
},
"productid": "35561-257_49fc9e85-3dc2-064f-e063-6294a90af582",
"productndc": "35561-257",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208824",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "Oct 27, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "5MG",
"product_no": "002",
"approval_date": "Oct 27, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "10MG",
"product_no": "003",
"approval_date": "Oct 27, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "20MG",
"product_no": "004",
"approval_date": "Oct 27, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TADALAFIL",
"proprietary_name": "N/A",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208824",
"marketing_category": "ANDA",
"nonproprietary_name": "Tadalafil",
"start_marketing_date": "20191129",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code G04BE08.
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