FDA Orange Book
Generic for Carnitor
Carnitor contains levocarnitine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Carnitor is levocarnitine. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP.
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Carnitor products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 200MG/ML | Marketed (Rx) | AP | 5 | AP |
| solution, oral | 1GM/10ML | Marketed (Rx) | AA | 4 | AA |
| solution, oral | 1GM/10ML | Discontinued | None | 4 | AA |
| tablet, oral | 330MG | Marketed (Rx) | AB | 2 | AB |
NDA 020182, 019257, 018948, held by LEADIANT BIOSCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic levocarnitine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 075567 | AP (A-rated, therapeutically equivalent) | March 29, 2001 | 200MG/ML |
| AMERICAN REGENT INC | 075861 | AP (A-rated, therapeutically equivalent) | June 22, 2001 | 200MG/ML |
| RISING PHARMA HOLDINGS INC | 076851 | AA (A-rated, therapeutically equivalent) | August 10, 2004 | 1GM/10ML, 1GM/10ML |
| RISING PHARMA HOLDINGS INC | 076858 | AB (A-rated, therapeutically equivalent) | September 20, 2004 | 330MG |
| NOVITIUM PHARMA LLC | 211676 | AA (A-rated, therapeutically equivalent) | August 14, 2019 | 1GM/10ML, 1GM/10ML, 1GM/10ML, 1GM/10ML |
| SCIEGEN PHARMACEUTICALS INC | 212533 | AA (A-rated, therapeutically equivalent) | November 10, 2021 | 1GM/10ML, 1GM/10ML |
| NOVITIUM PHARMA LLC | 216384 | AB (A-rated, therapeutically equivalent) | December 9, 2022 | 330MG |
| DEVA HOLDING AS | 217430 | AP (A-rated, therapeutically equivalent) | June 30, 2025 | 200MG/ML |
| BAXTER HEALTHCARE CORP | 217896 | AP (A-rated, therapeutically equivalent) | July 2, 2026 | 200MG/ML |
| GLAND PHARMA LTD | 220181 | AP (A-rated, therapeutically equivalent) | September 30, 2026 | 200MG/ML |
Carnitor NDC codes
Questions
Is there a generic for Carnitor?
Yes. The generic name for Carnitor is levocarnitine. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP.
What is the generic name for Carnitor?
The active ingredient in Carnitor is levocarnitine, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.