Tresiba is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Novo Nordisk. The primary component is Insulin Degludec.
Product ID | 0169-2660_b7aeb64e-5f1b-458e-ae42-e89ba622a60a |
NDC | 0169-2660 |
Product Type | Human Prescription Drug |
Proprietary Name | Tresiba |
Generic Name | Insulin Degludec Injection |
Dosage Form | Injection, Solution |
Route of Administration | SUBCUTANEOUS |
Marketing Start Date | 2015-09-25 |
Marketing Category | BLA / NDA |
Application Number | BLA203314 |
Labeler Name | Novo Nordisk |
Substance Name | INSULIN DEGLUDEC |
Active Ingredient Strength | 100 U/mL |
Pharm Classes | Insulin [CS],Insulin Analog [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2021-12-31 |
Marketing Start Date | 2015-09-25 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA203314 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2015-09-25 |
Marketing Category | NDA |
Application Number | NDA203314 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2015-09-25 |
Marketing Category | NDA |
Application Number | NDA203314 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2019-11-20 |
Ingredient | Strength |
---|---|
INSULIN DEGLUDEC | 100 U/mL |
SPL SET ID: | 456c5e87-3dfd-46fa-8ac0-c6128d4c97c6 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
NDC | Brand Name | Generic Name |
---|---|---|
0169-2550 | Tresiba | insulin degludec injection |
0169-2660 | Tresiba | insulin degludec injection |
0169-2662 | Tresiba | insulin degludec injection |
50090-3491 | Tresiba | insulin degludec |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TRESIBA 79080004 3841743 Live/Registered |
Novo Nordisk A/S 2010-02-03 |