Medicine
Dextenza 0.4 mg ophthalmic insert
Dextenza 0.4 mg ophthalmic insert is a prescription medicine containing Dexamethasone for intracanalicular, ophthalmic use, marketed by Ocular Therapeutix, 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store refrigerated, between 2°C and 8°C (36°F and 46°F). Do not freeze…
Key facts
- Active ingredient (INN)
- Dexamethasone
- Brand
- Dextenza
- Strength
- 0.4 mg
- Dosage form
- Ophthalmic insert
- Route
- Intracanalicular, ophthalmic
- Packs
- 1 pouch, 10 pouches
- Marketing authorisation holder
- Ocular Therapeutix
- Manufacturer
- Ocular Therapeutix
- Origin register
- US FDA, United States
- Storage
- Store refrigerated, between 2°C and 8°C (36°F and 46°F). Do not freeze. Protect from light, keep in package until use.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A01AC02 Dexamethasone
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 January 2019
- Identifiers
- RxCUI 2108015, 2108020DailyMed set ID 7514e6b8-c33f-4fbf-8810-ef520e1eb4bdNDC 70382-204Application NDA208742
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 |
|---|---|---|---|
| 1 pouch in 1 box, unit-dose / 1 insert in 1 pouch | 70382-204-01 | Ocular Therapeutix | 7 January 2019 |
| 10 pouch in 1 box, unit-dose / 1 insert in 1 pouch | 70382-204-10 | Ocular Therapeutix | 7 January 2019 |
| 1 pouch in 1 box, unit-dose / 1 insert in 1 pouch | 70382-204-99 | Ocular Therapeutix | 7 January 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.
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
Other strengths and forms of Dexamethasone
Clinical summary
Dexamethasone is a corticosteroid. It is available as tablets, injection and elixir for oral, intramuscular and intravenous use. MedsAcross supplies Dexamethasone 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 DexamethasoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- MAXIDEX prescribing information (Harrow Eye) · U.S. National Library of Medicine, DailyMed
- Neofordex: European public assessment report (EPAR) · European Medicines Agency
- Ozurdex: European public assessment report (EPAR) · European Medicines Agency
Need Dextenza 0.4 mg ophthalmic insert 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.