Last Updated: September 24, 2026

Details for New Drug Application (NDA): 076851

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NDA 076851 describes LEVOCARNITINE, which is a drug marketed by Am Regent, Baxter Hlthcare Corp, Deva Holding As, Hikma, Teva Pharms Usa, Novitium Pharma, Rising, and Sciegen Pharms, and is included in eleven NDAs. It is available from eight suppliers. Additional details are available on the LEVOCARNITINE profile page.

The generic ingredient in LEVOCARNITINE is levocarnitine. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the levocarnitine profile page.

Summary for 076851

Tradename:	LEVOCARNITINE
Applicant:	Rising
Ingredient:	levocarnitine
Patents:	0

Pharmacology for NDA: 076851

Suppliers and Packaging for NDA: 076851

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOCARNITINE	levocarnitine	SOLUTION;ORAL	076851	ANDA	Rising Pharma Holdings, Inc.	64980-503	64980-503-12	118 mL in 1 BOTTLE, PLASTIC (64980-503-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	1GM/10ML
Approval Date:	Aug 10, 2004	TE:	AA	RLD:	No

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