Medicine
Ephedrine 25 mg/5 mL injection
Ephedrine 25 mg/5 mL injection is a generic prescription medicine for intravenous 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 Ephedrine Sulfate Injection, USP 5 mg/mL at 20°C to 25°C (68°F to 77°F)…
Key facts
- Active ingredient (INN)
- Ephedrine
- Brand
- Sold under the generic name
- Strength
- 25 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 syringes of 5 mL
- Manufacturers
- Fresenius KabiHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store Ephedrine Sulfate Injection, USP 5 mg/mL at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store in carton until time of use. Protect from Light Contains No Preservatives Manufactured for: www.fresenius-kabi.com/us Made in Austria 451838 Fresenius Kabi Logo
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01CA26 Ephedrine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 December 2024
- Identifiers
- RxCUI 2586841, 2631017DailyMed set ID c021fe1b-3ac3-4577-b780-f6a3070908a1, 24787cb1-23e8-4baa-9838-a31a466b8c79NDC 65219-546, 0641-6236Application ANDA218271, ANDA217721
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 |
|---|---|---|---|
| 10 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic | 65219-546-05 | Fresenius Kabi | 7 July 2025 |
| 10 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic | 0641-6236-10 | Hikma Pharmaceuticals | 20 December 2024 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 29 April 2016 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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 Ephedrine 25 mg/5 mL injection.
Other strengths and forms of Ephedrine
Clinical summary
Ephedrine is a norepinephrine releasing agent indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. It is available as injection for intravenous use. MedsAcross supplies Ephedrine 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 EphedrineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Akovaz prescribing information (Exela Pharma Sciences) · U.S. National Library of Medicine, DailyMed
Need Ephedrine 25 mg/5 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.