Medicine
Dexamethasone 10 mg/1 mL injection
Dexamethasone 10 mg/1 mL injection is a generic prescription medicine for intra-articular, intralesional, intramuscular, intravenous, soft tissue use, made by 2 labelers, 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
Store at 20° to 25°C (68° to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Dexamethasone
- Brand
- Sold under the generic name
- Strength
- 10 mg/1 mL
- Dosage form
- Injection
- Route
- Intra-articular, intralesional, intramuscular, intravenous, soft tissue
- Packs
- 25 vials of 1 mL
- Manufacturers
- Gland PharmaIndiaSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from light.
- Cold chain
- Not required on record
- 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
- 25 September 2023
- Identifiers
- RxCUI 1116927, 1812079, 1812194DailyMed set ID 4680d517-ed5a-4137-819c-122ee962a464, c9d9ab76-6bc6-433d-aad7-8d49064ed745NDC 25021-053, 68083-607Application ANDA215654
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 68083-607-25 | Gland PharmaIndia | 25 September 2023 |
| 25 vial in 1 carton / 1 mL in 1 vial | 25021-053-01 | Sagent Pharmaceuticals | 1 December 2024 |
| 25 vial in 1 carton / 1 mL in 1 vial | 55150-304-25 | — | 5 June 2020 |
| 1 vial in 1 carton / 1 mL in 1 vial | 42571-432-40 | — | 1 August 2026 |
| 25 vial in 1 carton / 1 mL in 1 vial | 42571-432-79 | — | 1 June 2024 |
| 25 vial in 1 tray / 1 mL in 1 vial | 63323-506-01 | — | 29 May 2003 |
| 25 vial in 1 tray / 1 mL in 1 vial | 63323-506-13 | — | 6 January 2025 |
| 25 vial in 1 tray / 1 mL in 1 vial | 63323-506-16 | — | 29 May 2003 |
| 25 vial in 1 carton / 1 mL in 1 vial | 70121-1399-5 | — | 26 August 2018 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 72485-118-25 | — | 22 April 2025 |
| 25 vial in 1 carton / 1 mL in 1 vial | 0641-0367-25 | — | 7 September 1982 |
| 25 vial in 1 carton / 1 mL in 1 vial | 70069-021-25 | — | 19 April 2018 |
| 1 mL in 1 vial | 85766-071-01 | — | 1 October 2025 |
| 25 vial in 1 tray / 1 mL in 1 vial | 85766-071-25 | — | 1 October 2025 |
| 25 vial in 1 tray / 1 mL in 1 vial | 85766-186-25 | — | 20 March 2026 |
| 25 vial in 1 carton / 1 mL in 1 vial | 50090-3541-0 | — | 16 August 2018 |
| 25 vial in 1 carton / 1 mL in 1 vial | 80425-0261-1 | — | 16 February 2023 |
| 5 vial in 1 bag / 1 mL in 1 vial | 55154-5118-5 | — | 7 September 1982 |
| 25 pouch in 1 case / 1 vial in 1 pouch / 1 mL in 1 vial | 51662-1343-3 | — | 22 December 2018 |
| 1 vial in 1 bag / 1 mL in 1 vial | 71872-7091-1 | — | 30 March 2018 |
| 25 vial in 1 carton / 1 mL in 1 vial | 70518-0532-1 | — | 17 May 2017 |
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 Dexamethasone 10 mg/1 mL injection.
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 Dexamethasone 10 mg/1 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.