tradjenta

Generic: linagliptin

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tradjenta
Generic Name linagliptin
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

linagliptin 5 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4383
Product ID 50090-4383_706b12b0-f37f-4e9c-9776-038d78f4b9de
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 500904383
Hyphenated Format 50090-4383

Supplemental Identifiers

RxCUI
1100702 1100706
UNII
3X29ZEJ4R2
NUI
N0000175912 N0000175913

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
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-4383-0)
source: ndc

Packages (1)

Ingredients (1)

linagliptin (5 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "706b12b0-f37f-4e9c-9776-038d78f4b9de", "openfda": {"nui": ["N0000175912", "N0000175913"], "unii": ["3X29ZEJ4R2"], "rxcui": ["1100702", "1100706"], "spl_set_id": ["b1da67d4-51e0-41b7-9fe1-7f38c0d1baa1"], "pharm_class_epc": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-4383-0)", "package_ndc": "50090-4383-0", "marketing_start_date": "20190624"}], "brand_name": "Tradjenta", "product_id": "50090-4383_706b12b0-f37f-4e9c-9776-038d78f4b9de", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "50090-4383", "generic_name": "linagliptin", "labeler_name": "A-S Medication Solutions", "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"}