FDA.reportPublic FDA data

Carnitor

Product NDC
54482-147
11-digit product format
544820147
Labeler code
54482
Product ID
54482-147_0a9cb8a2-c17d-9bd3-e063-6294a90ac0e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levocarnitine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Leadiant Biosciences, Inc.
Application
NDA020182
Marketing category
NDA
Marketing start
1992-12-16
Substance
LEVOCARNITINE
Active strength
1 g/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0G389FZZ9M
Rxcui206345, 1791371

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
54482-147-01Carnitor5 in 1 CARTONINJECTION, SOLUTION519
54482-147-01Carnitor5 mL in 1 VIALINJECTION, SOLUTION519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54482-147-01ML - Milliliter54482-147d86a1f1b-a608-4cc7-bf09-3f4d326c753912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOCARNITINEACTIVE INGREDIENT0G389FZZ9MCARNITOR (LEVOCARNITINE) INJECTION, SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]8
LEVOCARNITINEACTIVE MOIETY0G389FZZ9MCARNITOR (LEVOCARNITINE) INJECTION, SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]8
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCARNITOR (LEVOCARNITINE) INJECTION, SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICARNITOR (LEVOCARNITINE) INJECTION, SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]8
WATERINACTIVE INGREDIENT059QF0KO0RCARNITOR (LEVOCARNITINE) INJECTION, SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54482-147CARNITOR (LEVOCARNITINE) INJECTION, SOLUTION [LEADIANT BIOSCIENCES, INC.]19Current NDC, Legacy NDC, 2 package rows20231122_cf801cc4-775e-433d-9d32-e5d9a98981d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206345CARNITOR 1 GM in 5 ML InjectionPSNcf801cc4-775e-433d-9d32-e5d9a98981d319
1791371levOCARNitine 1 GM in 5 ML InjectionPSNcf801cc4-775e-433d-9d32-e5d9a98981d319
2063455 ML levocarnitine 200 MG/ML Injection [Carnitor]SBDcf801cc4-775e-433d-9d32-e5d9a98981d319
17913715 ML levocarnitine 200 MG/ML InjectionSCDcf801cc4-775e-433d-9d32-e5d9a98981d319
2063455 ML Carnitor 200 MG/ML InjectionSYcf801cc4-775e-433d-9d32-e5d9a98981d319
206345Carnitor 1 GM per 5 ML InjectionSYcf801cc4-775e-433d-9d32-e5d9a98981d319
1791371levocarnitine 1 GM per 5 ML InjectionSYcf801cc4-775e-433d-9d32-e5d9a98981d319

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54482-147-01544820147015 VIAL in 1 CARTON (54482-147-01) / 5 mL in 1 VIAL5 vial1992-12-160000-00-00NoNoCurrent