Medicine
Levocarnitine 4000 mg/20 mL injection
Levocarnitine 4000 mg/20 mL injection is a generic prescription medicine for intravenous use, 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
Do not freeze. Store at or below 25°C (77°F). Store vials in carton until…
Key facts
- Active ingredient (INN)
- Levocarnitine
- Brand
- Sold under the generic name
- Strength
- 4000 mg/20 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 20 mL
- Manufacturer
- American Regent
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at or below 25°C (77°F). Store vials in carton until their use to protect from light.
- Cold chain
- Not required on record
- 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
- 21 June 2023
- Identifiers
- RxCUI 1791371, 2673428DailyMed set ID cc4da2c3-f939-444d-9b5b-a57b6051c190NDC 0517-1075Application ANDA075861
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 |
|---|---|---|---|
| 1 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 0517-1075-01 | American Regent | 21 June 2023 |
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 27 December 1985 | 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
Other strengths and forms of Levocarnitine
Clinical summary
Levocarnitine is a carnitine analog indicated in the treatment of primary systemic carnitine deficiency, among other approved uses. It is available as injection, oral solution and tablets for intravenous use. MedsAcross supplies Levocarnitine 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 LevocarnitineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- CARNITOR prescribing information (Leadiant Biosciences) · U.S. National Library of Medicine, DailyMed
Need Levocarnitine 4000 mg/20 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.