Medicine
Dexamethasone 0.5 mg/5 mL elixir
Dexamethasone 0.5 mg/5 mL elixir is a generic prescription medicine for oral use, made by 7 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
AVOID FREEZING. Store at 25ºC (77ºF), excursions permitted from 15º to 30º C…
Key facts
- Active ingredient (INN)
- Dexamethasone
- Brand
- Sold under the generic name
- Strength
- 0.5 mg/5 mL
- Dosage form
- Elixir
- Route
- Oral
- Packs
- 1 bottle, 237 mL, 20 cup and 4 more
- Manufacturers
- ANI PharmaceuticalsBryant Ranch PrepackChartwell RXKanchan HealthcareKesin PharmaMarlex PharmaceuticalsRising Pharma Holdings
- Origin register
- US FDA, United States
- Storage
- AVOID FREEZING. Store at 25ºC (77ºF), excursions permitted from 15º to 30º C (59º to 86ºF).
- 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
- 21 September 1976
- Identifiers
- RxCUI 309686DailyMed set ID 5d9b22ca-c619-4ee3-98eb-74544d0d5cb3, 7b51ffce-ec64-4b49-8870-b9666537c541, 02f7bf9c-1aa3-4734-8a3e-1f49498055d7 +4NDC 70954-872, 10135-795, 85742-004 +4Application ANDA084754, ANDA091188, ANDA090891
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 |
|---|---|---|---|
| 1 bottle in 1 carton / 237 mL in 1 bottle | 70954-872-10 | ANI Pharmaceuticals | 1 December 2025 |
| 237 mL in 1 bottle | 62135-114-37 | Chartwell RX | 13 January 2023 |
| 237 mL in 1 bottle | 85742-004-03 | Kanchan Healthcare | 14 November 2025 |
| 237 mL in 1 bottle, plastic | 64980-509-24 | Rising Pharma Holdings | 1 August 2011 |
| 237 mL in 1 bottle | 72162-2600-2 | Bryant Ranch Prepack | 9 January 2026 |
| 20 cup, unit-dose in 1 carton / 5 mL in 1 cup, unit-dose | 81033-010-24 | Kesin Pharma | 24 November 2025 |
| 237 mL in 1 bottle, glass | 10135-795-71 | Marlex Pharmaceuticals | 21 September 1976 |
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 Dexamethasone 0.5 mg/5 mL elixir 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.