FDA.reportPublic FDA data

Carnitor

Product NDC
54482-145
11-digit product format
544820145
Labeler code
54482
Product ID
54482-145_c1636127-9b6a-4443-81d9-e2607ae46e33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levocarnitine
Dosage form
SOLUTION
Route
ORAL
Labeler
Leadiant Biosciences, Inc.
Application
NDA019257
Marketing category
NDA
Marketing start
1986-04-10
Substance
LEVOCARNITINE
Active strength
1 g/10mL
Pharmacologic classes
Carnitine Analog [EPC], Carnitine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carnitor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOCARNITINE1 g/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0G389FZZ9M
Rxcui206343, 315134

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
08c722ec-780f-bb7b-8f14-3d4f7bf0e098Product name220240205
e2f276e5-439f-b432-b5e5-b0cfa993da69Product name320220609
4585a4fb-0028-3d95-020c-9b1c40bf15e0Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54482-145-08Carnitor24 in 1 CASESOLUTION2423
54482-145-08Carnitor118 mL in 1 BOTTLE, PLASTICSOLUTION11823
54482-145-09Carnitor118 mL in 1 BOTTLE, PLASTICSOLUTION11823
54482-145-09Carnitor24 in 1 CASESOLUTION2423

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54482-145-08ML - Milliliter54482-14592b6dfb7-ffa4-4298-a2fb-2c1dab9ae1ad12012-07-24
54482-145-09ML - Milliliter54482-145df78f355-8875-4cf9-a62d-27a68d5fb56912024-09-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOCARNITINEACTIVE INGREDIENT0G389FZZ9MCARNITOR (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]6
LEVOCARNITINEACTIVE MOIETY0G389FZZ9MCARNITOR (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]6
MALIC ACIDINACTIVE INGREDIENT817L1N4CKPCARNITOR (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCARNITOR (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCARNITOR (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]6
SUCROSEINACTIVE INGREDIENTC151H8M554CARNITOR (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RCARNITOR (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54482-145CARNITOR (LEVOCARNITINE) SOLUTION [LEADIANT BIOSCIENCES, INC.]23Current NDC, Legacy NDC, 4 package rows20240504_b2cbc620-59fd-47b6-9e4b-7e3e31533a1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206343Carnitor 1 GM in 10 mL Oral SolutionPSNb2cbc620-59fd-47b6-9e4b-7e3e31533a1c23
315134levOCARNitine 1 GM in 10 mL Oral SolutionPSNb2cbc620-59fd-47b6-9e4b-7e3e31533a1c23
206343levocarnitine 100 MG/ML Oral Solution [Carnitor]SBDb2cbc620-59fd-47b6-9e4b-7e3e31533a1c23
315134levocarnitine 100 MG/ML Oral SolutionSCDb2cbc620-59fd-47b6-9e4b-7e3e31533a1c23
206343Carnitor 1 GM per 10 ML Oral SolutionSYb2cbc620-59fd-47b6-9e4b-7e3e31533a1c23
206343Carnitor 100 MG/ML Oral SolutionSYb2cbc620-59fd-47b6-9e4b-7e3e31533a1c23
315134levocarnitine 1 GM per 10 ML Oral SolutionSYb2cbc620-59fd-47b6-9e4b-7e3e31533a1c23
315134levocarnitine 10 % Oral SolutionSYb2cbc620-59fd-47b6-9e4b-7e3e31533a1c23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54482-145-085448201450824 BOTTLE, PLASTIC in 1 CASE (54482-145-08) / 118 mL in 1 BOTTLE, PLASTIC1986-04-100000-00-00NoNoCurrent
54482-145-095448201450924 BOTTLE, PLASTIC in 1 CASE (54482-145-09) / 118 mL in 1 BOTTLE, PLASTIC2024-03-01NoNoHistorical