FDA Orange Book

Generic for Carnitor SF

Carnitor SF 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 SF is levocarnitine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.

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Carnitor SF products in the Orange Book

Carnitor SF products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution, oral1GM/10MLMarketed (Rx)AA4AA

NDA 019257, 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

Approved generic versions of Carnitor SF
CompanyANDATE codeApprovedStrengths
RISING PHARMA HOLDINGS INC076851AA (A-rated, therapeutically equivalent)August 10, 20041GM/10ML
NOVITIUM PHARMA LLC211676AA (A-rated, therapeutically equivalent)August 14, 20191GM/10ML, 1GM/10ML
SCIEGEN PHARMACEUTICALS INC212533AA (A-rated, therapeutically equivalent)November 10, 20211GM/10ML

Carnitor SF NDC codes

Questions

Is there a generic for Carnitor SF?

Yes. The generic name for Carnitor SF is levocarnitine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.

What is the generic name for Carnitor SF?

The active ingredient in Carnitor SF 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.

More on Carnitor SF and Levocarnitine

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