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Medicine

Tresiba 100 units/mL injection

Insulin degludec · Subcutaneous · Novo Nordisk
Available on requestPrescription onlyUS FDA Cold chain

Tresiba 100 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. It ships in a temperature-controlled cold chain.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Cold chain

Store unused TRESIBA in a refrigerator (36ºF to 46ºF [2ºC to 8ºC]). Do not…

Key facts

Active ingredient (INN)
Insulin degludec
Brand
Tresiba
Strength
100 units/mL
Dosage form
Injection
Route
Subcutaneous
Packs
5 syringes, 1 syringe, 1 vial and 1 more
Marketing authorisation holder
Novo Nordisk
Manufacturer
Novo Nordisk
Origin register
US FDA, United States
Storage
Store unused TRESIBA in a refrigerator (36ºF to 46ºF [2ºC to 8ºC]). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze. The storage conditions are summarized in Table 18: Table 18: Storage Conditions for TRESIBA Not in-use (unopened) In-use (opened) Refrigerated (36°F to 46°F [2°C to 8°C]) Room Temperature (up to 86°F [30°C]) Room Temperature (up…
Cold chain
Yes, shipped temperature controlled
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 1670011, 1670016, 1670021 +3DailyMed set ID 456c5e87-3dfd-46fa-8ac0-c6128d4c97c6NDC 0169-2662, 0169-2660Application 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

PackCodeLabelerMarketed since
5 syringe, plastic in 1 carton / 3 mL in 1 syringe, plastic0169-2660-15Novo Nordisk25 September 2015
1 syringe, plastic in 1 carton / 3 mL in 1 syringe, plastic0169-2660-97Novo Nordisk25 September 2015
1 vial, glass in 1 carton / 10 mL in 1 vial, glass0169-2662-11Novo Nordisk5 February 2019
1 vial, glass in 1 carton / 10 mL in 1 vial, glass0169-2662-90Novo Nordisk5 February 2019

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 25 September 2015Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

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 100 units/mL injection.

Compare 1

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 degludec

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Tresiba 100 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.