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United States · US · US:0597-0140_80d5d700-e711-462e-b291-3684a78d00b8
Tradjenta
Orange BookUNIISPLATC A10BH05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA10BH05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11059701403030 TABLET, FILM COATED in 1 BOTTLE (0597-0140-30)
- ndc110597014061100 BLISTER PACK in 1 CARTON (0597-0140-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1105970140707 BLISTER PACK in 1 CARTON (0597-0140-70) / 1 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11059701409090 TABLET, FILM COATED in 1 BOTTLE (0597-0140-90)
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": "0597-0140_80d5d700-e711-462e-b291-3684a78d00b8",
"productndc": "0597-0140",
"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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