CARNITOR
CARNITOR (levocarnitine) Tablets (330 mg)
Approved
Approval ID
d2133bc3-9c15-48bd-8b16-b8995a6a14cd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2023
Manufacturers
FDA
Leadiant Biosciences, Inc.
DUNS: 068301431
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 Code54482-144
Application NumberNDA018948
Product Classification
M
Marketing Category
C73594
G
Generic Name
levocarnitine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2023
FDA Product Classification
INGREDIENTS (4)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
LEVOCARNITINEActive
Quantity: 330 mg in 1 1
Code: 0G389FZZ9M
Classification: ACTIB