Medicine
Dexamethasone 4 mg/1 mL injection
Dexamethasone 4 mg/1 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 3 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 container in carton until contents have been used.
Key facts
- Active ingredient (INN)
- Dexamethasone
- Brand
- Sold under the generic name
- Strength
- 4 mg/1 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 25 vials of 1 mL, 5 vials of 1 mL and 2 more
- Manufacturers
- Fresenius KabiCardinal HealthPhlow
- Origin register
- US FDA, United States
- Storage
- Store container in carton until contents have been used.
- 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
- 7 September 2000
- Identifiers
- RxCUI 1812194, 1116927DailyMed set ID 02d25ab8-8f51-452b-b944-f569fbae36fe, 6d3cbd54-93ef-40fe-b15a-7a4f52dc5f71, 2b626a48-c7aa-4443-9164-a08ff069ccd1 +1NDC 81565-202, 55154-9364, 63323-165Application ANDA084916
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 in 1 tray / 1 mL in 1 vial | 63323-165-01 | Fresenius Kabi | 7 September 2000 |
| 25 vial in 1 tray / 1 mL in 1 vial | 63323-165-16 | Fresenius Kabi | 7 September 2000 |
| 25 vial in 1 tray / 1 mL in 1 vial | 63323-165-51 | Fresenius Kabi | 17 February 2025 |
| 25 vial in 1 tray / 1 mL in 1 vial | 81565-202-02 | Phlow | 15 December 2021 |
| 5 vial in 1 bag / 1 mL in 1 vial | 55154-9364-5 | Cardinal Health | 7 September 2000 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 55150-237-01 | — | 1 December 2015 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 68083-473-25 | — | 4 August 2021 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 70121-1450-5 | — | 27 August 2018 |
| 24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 1 mL in 1 syringe, glass | 76045-210-10 | — | 30 November 2020 |
| 25 vial in 1 carton / 1 mL in 1 vial | 0641-6145-25 | — | 15 July 1975 |
| 25 vial in 1 carton / 1 mL in 1 vial | 67457-423-12 | — | 11 May 2011 |
| 25 vial in 1 carton / 1 mL in 1 vial | 25021-052-01 | — | 1 December 2024 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 70069-022-25 | — | 8 June 2018 |
| 1 mL in 1 vial, single-dose | 76420-077-01 | — | 11 February 2020 |
| 1 mL in 1 vial | 76420-185-01 | — | 21 November 2020 |
| 25 vial in 1 carton / 1 mL in 1 vial | 76420-396-01 | — | 31 May 2025 |
| 1 mL in 1 vial | 76420-555-01 | — | 4 April 2023 |
| 25 vial in 1 carton / 1 mL in 1 vial | 87063-290-25 | — | 7 August 2026 |
| 1 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose | 71872-7092-1 | — | 30 March 2018 |
| 1 vial in 1 bag / 1 mL in 1 vial | 71872-7153-1 | — | 6 February 2019 |
| 1 vial in 1 bag / 1 mL in 1 vial | 71872-7164-1 | — | 6 May 2019 |
| 1 vial in 1 bag / 1 mL in 1 vial | 71872-7171-1 | — | 27 June 2019 |
| 25 vial in 1 carton / 1 mL in 1 vial | 70518-3019-0 | — | 8 February 2021 |
| 25 vial in 1 carton / 1 mL in 1 vial | 70518-3724-0 | — | 25 April 2023 |
| 25 vial in 1 carton / 1 mL in 1 vial | 70518-4372-0 | — | 25 June 2025 |
| 25 vial in 1 carton / 1 mL in 1 vial | 50090-1922-0 | — | 15 July 2015 |
| 1 vial in 1 carton / 1 mL in 1 vial | 50090-1922-1 | — | 2 April 2024 |
| 25 vial in 1 carton / 1 mL in 1 vial | 72572-120-25 | — | 13 November 2019 |
| 25 pouch in 1 case / 1 mL in 1 pouch | 51662-1297-3 | — | 11 January 2021 |
| 25 vial in 1 carton / 1 mL in 1 vial | 85766-217-25 | — | 10 July 2026 |
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 4 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 4 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.