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Levocarnitine

Levocarnitine Tablets USP (330 mg)

Approved
Approval ID

c8a590a7-628b-45c5-ac2c-24214a69eaa6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 10, 2022

Manufacturers
FDA

Akorn

DUNS: 117696873

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Levocarnitine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50383-172
Application NumberNDA018948
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levocarnitine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2022
FDA Product Classification

INGREDIENTS (4)

LEVOCARNITINEActive
Quantity: 330 mg in 1 1
Code: 0G389FZZ9M
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT

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Levocarnitine - FDA Drug Approval Details