Medicine
Omegaven 10 g/100 mL injectable emulsion
Omegaven 10 g/100 mL injectable emulsion is a prescription medicine containing Fish oil for intravenous use, marketed by Fresenius Kabi, 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
Do not freeze. If not used immediately, admixtures can be stored for up to 6…
Key facts
- Active ingredient (INN)
- Fish oil
- Brand
- Omegaven
- Strength
- 10 g/100 mL
- Dosage form
- Injectable emulsion
- Route
- Intravenous
- Packs
- 10 vials of 100 mL
- Marketing authorisation holder
- Fresenius Kabi
- Manufacturer
- Fresenius Kabi
- Origin register
- US FDA, United States
- Storage
- Do not freeze. If not used immediately, admixtures can be stored for up to 6 hours at room temperature or up to 24 hours under refrigeration. Store below 25°C (77°F). Complete the infusion within 24 hours after removal from storage.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 July 2018
- Identifiers
- RxCUI 2053499, 2053504, 2053513 +1DailyMed set ID 5d9d0b24-e139-48bf-ab2d-536fb59cf8e0NDC 63323-205Application NDA210589
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 |
|---|---|---|---|
| 10 vial, single-dose in 1 carton / 100 mL in 1 vial, single-dose | 63323-205-00 | Fresenius Kabi | 27 July 2018 |
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 |
| 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
Other strengths and forms of Fish oil
Clinical summary
Fish oil is a prescription medicine indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC), among other approved uses. It is available as injectable emulsion for intravenous use. MedsAcross supplies Fish oil 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 Fish oilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Omegaven prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Omegaven 10 g/100 mL injectable emulsion 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.