Prescription drug · BLA
Tresiba (Insulin degludec) NDC 0169-2550
Insulin degludec 200 U/mL · Injection, Solution · Subcutaneous · Novo Nordisk
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0169-2550-13 | 0016925501300169255013 | 3 SYRINGE, PLASTIC in 1 CARTON (0169-2550-13) / 3 mL in 1 SYRINGE, PLASTICMarketed from Sep 25, 2015 | |
| 0169-2550-97 | 0016925509700169255097 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-2550-97) / 3 mL in 1 SYRINGE, PLASTIC (0169-2550-90)Marketed from Sep 25, 2015 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Tresiba
- Generic name (nonproprietary)
- insulin degludec
- Active ingredients
- Insulin degludec — 200 U/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Novo NordiskNDC labeler code 0169
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 203314
- Marketing start
- Listing expires
- Other FDA classes
- Insulin (Chemical structure)
- Identifiers
- Product ID 0169-2550_e5571110-ca7e-4fcc-88a8-9f1d0104c508SPL ID e5571110-ca7e-4fcc-88a8-9f1d0104c508SPL set ID 456c5e87-3dfd-46fa-8ac0-c6128d4c97c6RxCUI 1670011, 1670016, 1670021, 1670023, 2107520, 2107522UNII 54Q18076QB
- Pharmacologic class
- Insulin Analog
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400169255013followed by a unit qualifier and the quantityPackage 00169-2550-13. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
TRESIBA is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use • Not recommended for the treatment of diabetic ketoacidosis. TRESIBA is a long-acting human insulin analog indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus ( 1 ). Limitations of Use: • Not recommended for the treatment of diabetic ketoacidosis.
Excerpt only. Read the full label for complete information.
About NDC 0169-2550
- What is NDC 0169-2550?
- 0169-2550 is the product NDC for Tresiba (insulin degludec), Insulin degludec 200 U/mL injection, solution, listed with the FDA by Novo Nordisk. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tresiba (Insulin degludec).
- What is the active ingredient?
- Insulin degludec.
- Who is the labeler?
- Novo Nordisk, NDC labeler code 0169. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tresiba?
- 4 other product NDCs are listed under this name. See all Tresiba NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tresiba products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tresibainsulin degludec | Insulin degludec 100 U/mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-2662 | 00169-2662-1100169-2662-90 |
| Tresibainsulin degludec | Insulin degludec 100 U/mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-2660 | 00169-2660-1500169-2660-97 |
| Tresibainsulin degludec | Insulin degludec 200 U/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-3491 | 50090-3491-00 |
| Tresibainsulin degludec | Insulin degludec 200 U/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-7094 | 50090-7094-00 |
Other NDCs under BLA 203314
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Insulin Degludec | Insulin degludec 200 U/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-7175 |
| Insulin Degludec | Insulin degludec 100 U/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-7176 |
| Insulin Degludec | Insulin degludec 100 U/mL | Injection, SolutionSubcutaneous | Novo Nordisk Pharma, Inc. | 73070-400 |
| Insulin Degludec | Insulin degludec 100 U/mL | Injection, SolutionSubcutaneous | Novo Nordisk Pharma, Inc. | 73070-403 |
| Insulin Degludec | Insulin degludec 200 U/mL | Injection, SolutionSubcutaneous | Novo Nordisk Pharma, Inc. | 73070-503 |
| Tresibainsulin degludec | Insulin degludec 100 U/mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-2660 |
| Tresibainsulin degludec | Insulin degludec 100 U/mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-2662 |
| Tresibainsulin degludec | Insulin degludec 200 U/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-3491 |
| Tresibainsulin degludec | Insulin degludec 200 U/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-7094 |