jentadueto xr

Generic: linagliptin and metformin hydrochloride

Labeler: boehringer ingelheim pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name jentadueto xr
Generic Name linagliptin and metformin hydrochloride
Labeler boehringer ingelheim pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

linagliptin 2.5 mg/1, metformin hydrochloride 1000 mg/1

Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0597-0270
Product ID 0597-0270_bded948b-6ae6-41aa-bc63-9600660a8dfc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208026
Listing Expiration 2026-12-31
Marketing Start 2016-05-27

Pharmacologic Class

Established (EPC)
dipeptidyl peptidase 4 inhibitor [epc]
Mechanism of Action
dipeptidyl peptidase 4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05970270
Hyphenated Format 0597-0270

Supplemental Identifiers

RxCUI
1796089 1796091 1796094 1796096
UNII
3X29ZEJ4R2 786Z46389E
NUI
N0000175912 N0000175913

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name jentadueto xr (source: ndc)
Generic Name linagliptin and metformin hydrochloride (source: ndc)
Application Number NDA208026 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
  • 1000 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0597-0270-12) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0270-73)
  • 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0270-94)
source: ndc

Packages (3)

0597-0270-12 1 BOTTLE in 1 CARTON (0597-0270-12) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE 0597-0270-73 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0270-73) 0597-0270-94 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0270-94)

Ingredients (2)

linagliptin (2.5 mg/1) metformin hydrochloride (1000 mg/1)

Linked Drug Pages (1)

Jentadueto XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bded948b-6ae6-41aa-bc63-9600660a8dfc", "openfda": {"nui": ["N0000175912", "N0000175913"], "unii": ["3X29ZEJ4R2", "786Z46389E"], "rxcui": ["1796089", "1796091", "1796094", "1796096"], "spl_set_id": ["3d02a4d4-d312-80b4-05c4-691b8f0aa7aa"], "pharm_class_epc": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "manufacturer_name": ["Boehringer Ingelheim Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0597-0270-12)  / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "0597-0270-12", "marketing_start_date": "20160527"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0270-73)", "package_ndc": "0597-0270-73", "marketing_start_date": "20160527"}, {"sample": false, "description": "180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0270-94)", "package_ndc": "0597-0270-94", "marketing_start_date": "20160527"}], "brand_name": "Jentadueto XR", "product_id": "0597-0270_bded948b-6ae6-41aa-bc63-9600660a8dfc", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "0597-0270", "generic_name": "linagliptin and metformin hydrochloride", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Jentadueto XR", "active_ingredients": [{"name": "LINAGLIPTIN", "strength": "2.5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "NDA208026", "marketing_category": "NDA", "marketing_start_date": "20160527", "listing_expiration_date": "20261231"}