Levocarnitine
Levocarnitine Oral Solution, USP
Approved
Approval ID
75b43fb1-4486-48a0-b571-7754dce350a3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2024
Manufacturers
FDA
Saptalis Pharmaceuticals, LLC
DUNS: 080145868
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levocarnitine Oral
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71656-016
Application NumberANDA212533
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levocarnitine Oral
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2024
FDA Product Classification
INGREDIENTS (8)
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
MALIC ACIDInactive
Code: 817L1N4CKP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
LEVOCARNITINEActive
Quantity: 1 g in 10 mL
Code: 0G389FZZ9M
Classification: ACTIB