🇺🇸
United States · US · US:0597-0275_bded948b-6ae6-41aa-bc63-9600660a8dfc
Jentadueto XR
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 · 3
- ndc11059702753330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0275-33)
- ndc11059702758190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0275-81)
- ndc1105970275881 BOTTLE in 1 CARTON (0597-0275-88) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
3X29ZEJ4R2
LINAGLIPTIN
RxCUI 1100699
Orange Book
N208026
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": "0597-0275_bded948b-6ae6-41aa-bc63-9600660a8dfc",
"productndc": "0597-0275",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "208026",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "2.5MG;1GM",
"product_no": "001",
"approval_date": "May 27, 2016"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "5MG;1GM",
"product_no": "002",
"approval_date": "May 27, 2016"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
"proprietary_name": "Jentadueto XR",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA208026",
"marketing_category": "NDA",
"nonproprietary_name": "linagliptin and metformin hydrochloride",
"start_marketing_date": "20160527",
"active_numerator_strength": "5; 1000"
}Related drugs
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- 🇺🇸alogliptin and metformin hydrochlorideA-S Medication Solutions
- 🇺🇸alogliptin and metformin hydrochloridePadagis Israel Pharmaceuticals Ltd
- 🇺🇸alogliptin and metformin hydrochloridePadagis Israel Pharmaceuticals Ltd
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