Levocarnitine
LEVOCARNITINE INJECTION, USP1 g per 5 mL vial and 4 g per 20 mL vialFOR INTRAVENOUS USE ONLYRx Only
Approved
Approval ID
cc4da2c3-f939-444d-9b5b-a57b6051c190
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 23, 2023
Manufacturers
FDA
American Regent, Inc.
DUNS: 002033710
Products 2
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 Code0517-1075
Application NumberANDA075861
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levocarnitine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 23, 2023
FDA Product Classification
INGREDIENTS (4)
LEVOCARNITINEActive
Quantity: 200 mg in 1 mL
Code: 0G389FZZ9M
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Levocarnitine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0517-1045
Application NumberANDA075861
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levocarnitine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 23, 2023
FDA Product Classification
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
LEVOCARNITINEActive
Quantity: 200 mg in 1 mL
Code: 0G389FZZ9M
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT