Medicine
Levocarnitine 1 g/10 mL oral solution
Levocarnitine 1 g/10 mL oral solution is a generic prescription medicine for oral use, made by 4 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 at controlled room temperature 15º to 30 ºC (59º to 86º F).
Key facts
- Active ingredient (INN)
- Levocarnitine
- Brand
- Sold under the generic name
- Strength
- 1 g/10 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 118 mL, 100 cup, 50 cup and 6 more
- Manufacturers
- Saptalis PharmaceuticalsANI PharmaceuticalsRising Pharma HoldingsTruPharma
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 15º to 30 ºC (59º to 86º 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
- 20 September 2004
- Identifiers
- RxCUI 315134DailyMed set ID 05ab18c1-fb01-48fa-8f05-0200bb8a5edf, 75b43fb1-4486-48a0-b571-7754dce350a3, 18dc8eae-56c1-46ec-9d21-e17d7b2f91db +1NDC 52817-830, 71656-016, 70954-140 +2Application ANDA212533, ANDA211676, ANDA076851
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 |
|---|---|---|---|
| 118 mL in 1 bottle | 70954-139-10 | ANI Pharmaceuticals | 14 August 2019 |
| 118 mL in 1 bottle | 70954-140-10 | ANI Pharmaceuticals | 14 August 2019 |
| 118 mL in 1 bottle, plastic | 64980-503-12 | Rising Pharma Holdings | 20 September 2004 |
| 100 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 71656-016-01 | Saptalis Pharmaceuticals | 21 February 2024 |
| 100 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose | 71656-016-02 | Saptalis Pharmaceuticals | 21 February 2024 |
| 118 mL in 1 bottle | 71656-016-04 | Saptalis Pharmaceuticals | 21 February 2024 |
| 50 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 71656-016-50 | Saptalis Pharmaceuticals | 21 February 2024 |
| 50 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose | 71656-016-51 | Saptalis Pharmaceuticals | 21 February 2024 |
| 118 mL in 1 bottle | 52817-830-04 | Trupharma | 9 February 2022 |
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/10 mL oral solution.
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/10 mL oral solution 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.