FDA Product

Levocarnitine

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Levocarnitine

FDA Product Code

0517-1075

Regulatory Information

NDC Product Code

0517-1075

Application Number

ANDA075861

Marketing Category

C73584

Effective Date

June 23, 2023

Territorial Authority

USA

FDA Title

LEVOCARNITINE INJECTION, USP1 g per 5 mL vial and 4 g per 20 mL vialFOR INTRAVENOUS USE ONLYRx Only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

11

Company Information

ManufacturerAmerican Regent, Inc.

DUNS Number

002033710

Active Ingredients

Quantity: 200 mg in 1 mL

Code: 0G389FZZ9M

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

Active Moieties

LEVOCARNITINE

Code: 0G389FZZ9M

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