Medicine
Tresiba 200 units/mL injection
Tresiba 200 units/mL injection is a prescription medicine containing Insulin degludec for subcutaneous use, marketed by Novo Nordisk, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
After first use store between 36 to 86 degrees F. Protect from light.
Key facts
- Active ingredient (INN)
- Insulin degludec
- Brand
- Tresiba
- Strength
- 200 units/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 3 syringes, 1 syringe and 1 more
- Marketing authorisation holder
- Novo Nordisk
- Manufacturers
- Novo NordiskA-S Medication Solutions
- Origin register
- US FDA, United States
- Storage
- After first use store between 36 to 86 degrees F. Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A10AD06 Insulin degludec
- HS code (indicative)
- 3004.31Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 September 2015
- Identifiers
- RxCUI 1670021, 1670023, 1670011 +3DailyMed set ID e8ccd2f4-6ba9-4839-87f8-4742dc9b1c17, 84197351-cb71-4282-8217-13103404a2b4, 456c5e87-3dfd-46fa-8ac0-c6128d4c97c6NDC 50090-7094, 50090-3491, 0169-2550Application BLA203314
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 3 syringe, plastic in 1 carton / 3 mL in 1 syringe, plastic | 0169-2550-13 | Novo Nordisk | 25 September 2015 |
| 1 syringe, plastic in 1 carton / 3 mL in 1 syringe, plastic | 0169-2550-97 | Novo Nordisk | 25 September 2015 |
| 3 syringe, plastic in 1 carton / 3 mL in 1 syringe, plastic | 50090-3491-0 | A-S Medication Solutions | 20 June 2018 |
| 3 syringe, plastic in 1 carton / 3 mL in 1 syringe, plastic | 50090-7094-0 | A-S Medication Solutions | 19 February 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Insulin degludec 200 units/mL injection.
Other strengths and forms of Insulin degludec
Clinical summary
Insulin degludec is an insulin analog indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. It is available as injection for subcutaneous use. MedsAcross supplies Insulin degludec for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Insulin degludecFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Insulin Degludec prescribing information (Novo Nordisk Pharma) · U.S. National Library of Medicine, DailyMed
- Tresiba: European public assessment report (EPAR) · European Medicines Agency
Need Tresiba 200 units/mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.