Medicine
Levocarnitine 1 g/5 mL injection
Levocarnitine 1 g/5 mL injection is a generic prescription medicine for intravenous use, made by 5 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
Protect from freezing. Store at 20°C to 25°C (68°F to 77°F).
Key facts
- Active ingredient (INN)
- Levocarnitine
- Brand
- Sold under the generic name
- Strength
- 1 g/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 5 vials of 5 mL, 10 vials of 5 mL and 2 more
- Manufacturers
- Gland PharmaIndiaAmerican RegentBaxter HealthcareDevatisHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store at 20°C to 25°C (68°F to 77°F).
- 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
- 1 June 2023
- Identifiers
- RxCUI 1791371, 2673428DailyMed set ID 1f38ab0d-ef89-4e92-990f-9da190057e17, 2685d8da-010e-40d7-914f-80546634888d, 79b6182c-ead5-4fdd-bafa-1afbc7a77906 +2NDC 36000-368, 68083-681, 73043-034 +2Application ANDA217896, ANDA220181, ANDA217430 +2
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 |
|---|---|---|---|
| 5 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 68083-681-05 | Gland PharmaIndia | 30 September 2026 |
| 5 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 0517-1045-05 | American Regent | 21 June 2023 |
| 10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 36000-368-10 | Baxter Healthcare | 2 July 2026 |
| 5 vial in 1 carton / 5 mL in 1 vial | 73043-034-05 | Devatis | 1 November 2025 |
| 10 vial, single-use in 1 carton / 5 mL in 1 vial, single-use | 0143-9852-10 | Hikma Pharmaceuticals | 1 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
Alternatives
Other makers and brands of Levocarnitine 1 g/5 mL injection.
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 1 g/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.