Levocarnitine
Levocarnitine Oral Solution USP 1g/10mL (118mL multidose)
Approved
Approval ID
ada35959-e317-4161-ae79-3475096c679f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2021
Manufacturers
FDA
Rising Pharmaceuticals, Inc.
DUNS: 041241766
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 Code64980-503
Application NumberANDA076851
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levocarnitine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2021
FDA Product Classification
INGREDIENTS (6)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
MALIC ACIDInactive
Code: 817L1N4CKP
Classification: IACT
LEVOCARNITINEActive
Quantity: 1 g in 10 mL
Code: 0G389FZZ9M
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT