jentadueto xr
Generic: linagliptin and metformin hydrochloride
Labeler: boehringer ingelheim pharmaceuticals, inc.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
Active Ingredients
linagliptin 5 mg/1, metformin hydrochloride 1000 mg/1
Manufacturer
Identifiers & Regulatory
Product NDC
0597-0275
Product ID
0597-0275_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)
Mechanism of Action
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
05970275
Hyphenated Format
0597-0275
Supplemental Identifiers
RxCUI
UNII
NUI
Packaging Origin
Original Packager
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
source: ndc
Resolved Composition
Strengths
- 5 mg/1
- 1000 mg/1
Packaging
- 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0275-33)
- 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0275-81)
- 1 BOTTLE in 1 CARTON (0597-0275-88) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Packages (3)
Ingredients (2)
Linked Drug Pages (1)
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": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0275-33)", "package_ndc": "0597-0275-33", "marketing_start_date": "20160527"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0275-81)", "package_ndc": "0597-0275-81", "marketing_start_date": "20160527"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0597-0275-88) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "0597-0275-88", "marketing_start_date": "20160527"}], "brand_name": "Jentadueto XR", "product_id": "0597-0275_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": "0597-0275", "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": "5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "NDA208026", "marketing_category": "NDA", "marketing_start_date": "20160527", "listing_expiration_date": "20261231"}