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United States · US · US:50090-4383_706b12b0-f37f-4e9c-9776-038d78f4b9de
Tradjenta
Orange BookUNIISPLATC A10BH05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeA10BH05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11500904383090 TABLET, FILM COATED in 1 BOTTLE (50090-4383-0)
Annotations
UNII (FDA Substance ID)
3X29ZEJ4R2
LINAGLIPTIN
RxCUI 1100699
Orange Book
N201280
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "3X29ZEJ4R2",
"rxcui": "1100699",
"inchikey": "LTXREWYXXSTFRX-QGZVFWFLSA-N",
"display_name": "LINAGLIPTIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"dfe327e8-f6ab-41e5-bdef-d520118cd83a": {
"match": "brand_token",
"title": "TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]",
"spl_version": "12",
"published_date": "2025-09-08"
}
},
"productid": "50090-4383_706b12b0-f37f-4e9c-9776-038d78f4b9de",
"productndc": "50090-4383",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "201280",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "May 2, 2011"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LINAGLIPTIN",
"proprietary_name": "Tradjenta",
"active_ingred_unit": "mg/1",
"application_number": "NDA201280",
"marketing_category": "NDA",
"nonproprietary_name": "linagliptin",
"start_marketing_date": "20110509",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code A10BH05.
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