jentadueto

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

linagliptin 2.5 mg/1, metformin hydrochloride 850 mg/1

Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0597-0147
Product ID 0597-0147_f5fe93f0-69ef-4ca2-adeb-c50582e25592
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA201281
Listing Expiration 2026-12-31
Marketing Start 2012-02-13

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 05970147
Hyphenated Format 0597-0147

Supplemental Identifiers

RxCUI
1243020 1243026 1243027 1243033 1243034 1243040
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 (source: ndc)
Generic Name linagliptin and metformin hydrochloride (source: ndc)
Application Number NDA201281 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
  • 850 mg/1
source: ndc
Packaging
  • 180 TABLET, FILM COATED in 1 BOTTLE (0597-0147-18)
  • 60 TABLET, FILM COATED in 1 BOTTLE (0597-0147-60)
source: ndc

Packages (2)

0597-0147-18 180 TABLET, FILM COATED in 1 BOTTLE (0597-0147-18) 0597-0147-60 60 TABLET, FILM COATED in 1 BOTTLE (0597-0147-60)

Ingredients (2)

linagliptin (2.5 mg/1) metformin hydrochloride (850 mg/1)

Linked Drug Pages (1)

Jentadueto ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f5fe93f0-69ef-4ca2-adeb-c50582e25592", "openfda": {"nui": ["N0000175912", "N0000175913"], "unii": ["3X29ZEJ4R2", "786Z46389E"], "rxcui": ["1243020", "1243026", "1243027", "1243033", "1243034", "1243040"], "spl_set_id": ["f6dd9b86-0d18-95d4-2bc7-05591bfdd597"], "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": "180 TABLET, FILM COATED in 1 BOTTLE (0597-0147-18)", "package_ndc": "0597-0147-18", "marketing_start_date": "20120213"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (0597-0147-60)", "package_ndc": "0597-0147-60", "marketing_start_date": "20120213"}], "brand_name": "Jentadueto", "product_id": "0597-0147_f5fe93f0-69ef-4ca2-adeb-c50582e25592", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "0597-0147", "generic_name": "linagliptin and metformin hydrochloride", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Jentadueto", "active_ingredients": [{"name": "LINAGLIPTIN", "strength": "2.5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "850 mg/1"}], "application_number": "NDA201281", "marketing_category": "NDA", "marketing_start_date": "20120213", "listing_expiration_date": "20261231"}