tresiba

Generic: insulin degludec

Labeler: novo nordisk
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name tresiba
Generic Name insulin degludec
Labeler novo nordisk
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

insulin degludec 200 U/mL

Manufacturer
Novo Nordisk

Identifiers & Regulatory

Product NDC 0169-2550
Product ID 0169-2550_e5571110-ca7e-4fcc-88a8-9f1d0104c508
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA203314
Listing Expiration 2026-12-31
Marketing Start 2015-09-25

Pharmacologic Class

Established (EPC)
insulin analog [epc]
Chemical Structure
insulin [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01692550
Hyphenated Format 0169-2550

Supplemental Identifiers

RxCUI
1670011 1670016 1670021 1670023 2107520 2107522
UNII
54Q18076QB
NUI
M0011417 N0000175453

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 tresiba (source: ndc)
Generic Name insulin degludec (source: ndc)
Application Number BLA203314 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 200 U/mL
source: ndc
Packaging
  • 3 SYRINGE, PLASTIC in 1 CARTON (0169-2550-13) / 3 mL in 1 SYRINGE, PLASTIC
  • 1 SYRINGE, PLASTIC in 1 CARTON (0169-2550-97) / 3 mL in 1 SYRINGE, PLASTIC (0169-2550-90)
source: ndc

Packages (2)

0169-2550-13 3 SYRINGE, PLASTIC in 1 CARTON (0169-2550-13) / 3 mL in 1 SYRINGE, PLASTIC 0169-2550-97 1 SYRINGE, PLASTIC in 1 CARTON (0169-2550-97) / 3 mL in 1 SYRINGE, PLASTIC (0169-2550-90)

Ingredients (1)

insulin degludec (200 U/mL)

Linked Drug Pages (1)

Tresiba ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "e5571110-ca7e-4fcc-88a8-9f1d0104c508", "openfda": {"nui": ["M0011417", "N0000175453"], "unii": ["54Q18076QB"], "rxcui": ["1670011", "1670016", "1670021", "1670023", "2107520", "2107522"], "spl_set_id": ["456c5e87-3dfd-46fa-8ac0-c6128d4c97c6"], "pharm_class_cs": ["Insulin [CS]"], "pharm_class_epc": ["Insulin Analog [EPC]"], "manufacturer_name": ["Novo Nordisk"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 SYRINGE, PLASTIC in 1 CARTON (0169-2550-13)  / 3 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0169-2550-13", "marketing_start_date": "20150925"}, {"sample": false, "description": "1 SYRINGE, PLASTIC in 1 CARTON (0169-2550-97)  / 3 mL in 1 SYRINGE, PLASTIC (0169-2550-90)", "package_ndc": "0169-2550-97", "marketing_start_date": "20150925"}], "brand_name": "Tresiba", "product_id": "0169-2550_e5571110-ca7e-4fcc-88a8-9f1d0104c508", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Insulin Analog [EPC]", "Insulin [CS]"], "product_ndc": "0169-2550", "generic_name": "insulin degludec", "labeler_name": "Novo Nordisk", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tresiba", "active_ingredients": [{"name": "INSULIN DEGLUDEC", "strength": "200 U/mL"}], "application_number": "BLA203314", "marketing_category": "BLA", "marketing_start_date": "20150925", "listing_expiration_date": "20261231"}