🇺🇸
United States · US · US:0597-0146_f5fe93f0-69ef-4ca2-adeb-c50582e25592
Jentadueto
Orange BookUNIISPLATC A10BH
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA10BH
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110597014618180 TABLET, FILM COATED in 1 BOTTLE (0597-0146-18)
- ndc11059701466060 TABLET, FILM COATED in 1 BOTTLE (0597-0146-60)
Annotations
UNII (FDA Substance ID)
3X29ZEJ4R2
LINAGLIPTIN
RxCUI 1100699
Orange Book
N201281
ABABAB
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": {
"f6dd9b86-0d18-95d4-2bc7-05591bfdd597": {
"match": "brand_token",
"title": "JENTADUETO (LINAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
"spl_version": "45",
"published_date": "2024-08-22"
}
},
"productid": "0597-0146_f5fe93f0-69ef-4ca2-adeb-c50582e25592",
"productndc": "0597-0146",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "201281",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "2.5MG;500MG",
"product_no": "001",
"approval_date": "Jan 30, 2012"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "2.5MG;850MG",
"product_no": "002",
"approval_date": "Jan 30, 2012"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "2.5MG;1GM",
"product_no": "003",
"approval_date": "Jan 30, 2012"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
"proprietary_name": "Jentadueto",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA201281",
"marketing_category": "NDA",
"nonproprietary_name": "linagliptin and metformin hydrochloride",
"start_marketing_date": "20120213",
"active_numerator_strength": "2.5; 500"
}Related drugs
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- 🇺🇸alogliptin and metformin hydrochloridePadagis Israel Pharmaceuticals Ltd
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