tradjenta

Generic: linagliptin

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

Drug Facts

Product Profile

Brand Name tradjenta
Generic Name linagliptin
Labeler boehringer ingelheim pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

linagliptin 5 mg/1

Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0597-0140
Product ID 0597-0140_80d5d700-e711-462e-b291-3684a78d00b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA201280
Listing Expiration 2026-12-31
Marketing Start 2011-05-09

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 05970140
Hyphenated Format 0597-0140

Supplemental Identifiers

RxCUI
1100702 1100706
UNII
3X29ZEJ4R2
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 tradjenta (source: ndc)
Generic Name linagliptin (source: ndc)
Application Number NDA201280 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0597-0140-30)
  • 100 BLISTER PACK in 1 CARTON (0597-0140-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 7 BLISTER PACK in 1 CARTON (0597-0140-70) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 90 TABLET, FILM COATED in 1 BOTTLE (0597-0140-90)
source: ndc

Packages (4)

0597-0140-30 30 TABLET, FILM COATED in 1 BOTTLE (0597-0140-30) 0597-0140-61 100 BLISTER PACK in 1 CARTON (0597-0140-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK 0597-0140-70 7 BLISTER PACK in 1 CARTON (0597-0140-70) / 1 TABLET, FILM COATED in 1 BLISTER PACK 0597-0140-90 90 TABLET, FILM COATED in 1 BOTTLE (0597-0140-90)

Ingredients (1)

linagliptin (5 mg/1)

Linked Drug Pages (1)

Tradjenta ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "80d5d700-e711-462e-b291-3684a78d00b8", "openfda": {"nui": ["N0000175912", "N0000175913"], "unii": ["3X29ZEJ4R2"], "rxcui": ["1100702", "1100706"], "spl_set_id": ["c797ea5c-cab7-494b-9044-27eba0cfe40f"], "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 in 1 BOTTLE (0597-0140-30)", "package_ndc": "0597-0140-30", "marketing_start_date": "20110509"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0597-0140-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0597-0140-61", "marketing_start_date": "20110509"}, {"sample": true, "description": "7 BLISTER PACK in 1 CARTON (0597-0140-70)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0597-0140-70", "marketing_end_date": "20260831", "marketing_start_date": "20110509"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (0597-0140-90)", "package_ndc": "0597-0140-90", "marketing_start_date": "20110509"}], "brand_name": "Tradjenta", "product_id": "0597-0140_80d5d700-e711-462e-b291-3684a78d00b8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "0597-0140", "generic_name": "linagliptin", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tradjenta", "active_ingredients": [{"name": "LINAGLIPTIN", "strength": "5 mg/1"}], "application_number": "NDA201280", "marketing_category": "NDA", "marketing_start_date": "20110509", "listing_expiration_date": "20261231"}