Active ingredient
Levocarnitine
16 finished FDA listings contain Levocarnitine as their only active ingredient; 10 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- LEVOCARNITINE
- Dosage forms
- Injection, Injection, Solution, Solution, Tablet
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 9
- Strengths listed
- 1 g/10ml · 1 g/5ml · 200 mg/ml · 330 mg/1
- Brand names in FDA listings
- Carnitor, Carnitor Sf, Levocarnitine
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 42955
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 018948 | LEADIANT BIOSCI INC | 1985-12-27 | 1 |
| NDA 019257 | LEADIANT BIOSCI INC | 1986-04-10 | 2 |
| NDA 020182 | LEADIANT BIOSCI INC | 1992-12-16 | 1 |
| ANDA 075567 | HIKMA | 2001-03-29 | 1 |
| ANDA 075861 | AM REGENT | 2001-06-22 | 2 |
| ANDA 076851 | RISING | 2004-08-10 | 1 |
| ANDA 076858 | RISING | 2004-09-20 | 1 |
| ANDA 211676 | NOVITIUM PHARMA | 2019-08-14 | 2 |
| ANDA 212533 | SCIEGEN PHARMS | 2021-11-10 | 2 |
| ANDA 216384 | NOVITIUM PHARMA | 2022-12-09 | 1 |
| ANDA 217430 | DEVA HOLDING AS | 2025-06-30 | 1 |
| ANDA 217896 | BAXTER HLTHCARE CORP | 2026-07-02 | 1 |
Official labeling on DailyMed
- LEVOCARNITINE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] · version 1 · 2026-07-17
- LEVOCARNITINE TABLET [ANI PHARMACEUTICALS, INC.] · version 4 · 2025-12-31
- LEVOCARNITINE SOLUTION [ANI PHARMACEUTICALS, INC.] · version 7 · 2025-12-31
- LEVOCARNITINE INJECTION, SOLUTION [DEVATIS INC.] · version 1 · 2025-11-17
- LEVOCARNITINE SOLUTION [RISING PHARMA HOLDINGS, INC.] · version 9 · 2025-07-21
- LEVOCARNITINE (LEVOCARNITINE ORAL) SOLUTION [SAPTALIS PHARMACEUTICALS, LLC] · version 4 · 2025-03-21
- LEVOCARNITINE SOLUTION [TRUPHARMA, LLC] · version 2 · 2024-12-30
- CARNITOR (LEVOCARNITINE) TABLET [LEADIANT BIOSCIENCES, INC.] · version 21 · 2024-11-14
- CARNITOR SF (LEVOCARNITINE) SOLUTION [LEADIANT BIOSCIENCES, INC.] · version 23 · 2024-11-14
- LEVOCARNITINE TABLET [RISING PHARMA HOLDINGS, INC.] · version 3 · 2024-09-27
- CARNITOR (LEVOCARNITINE) SOLUTION [LEADIANT BIOSCIENCES, INC.] · version 23 · 2024-05-06
- LEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.] · version 11 · 2024-01-23
Showing the 12 most recent of 14 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.