CARNITOR

Product NDC
54482-144
11-digit product format
544820144
Labeler code
54482
Product ID
54482-144_24e9abdb-6e9d-4f27-9e0f-8e8a3a462615
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levocarnitine
Dosage form
TABLET
Route
ORAL
Labeler
Leadiant Biosciences, Inc.
Application
NDA018948
Marketing category
NDA
Marketing start
1985-12-27
Substance
LEVOCARNITINE
Active strength
330 mg/1
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
LEVOCARNITINE330 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0G389FZZ9M
Rxcui197448, 206346

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
54482-144-07CARNITOR9 in 1 BLISTER PACKTABLET921
54482-144-07CARNITOR10 in 1 CARTONTABLET1021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54482-144-07EA - Each54482-144a7ad5de8-1614-40ab-9488-94086a0e9d5612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOCARNITINEACTIVE INGREDIENT0G389FZZ9MCARNITOR (LEVOCARNITINE) TABLET [SIGMA-TAU PHARMACEUTICALS, INC.]8
LEVOCARNITINEACTIVE MOIETY0G389FZZ9MCARNITOR (LEVOCARNITINE) TABLET [SIGMA-TAU PHARMACEUTICALS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARNITOR (LEVOCARNITINE) TABLET [SIGMA-TAU PHARMACEUTICALS, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARNITOR (LEVOCARNITINE) TABLET [SIGMA-TAU PHARMACEUTICALS, INC.]8
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARNITOR (LEVOCARNITINE) TABLET [SIGMA-TAU PHARMACEUTICALS, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54482-144CARNITOR (LEVOCARNITINE) TABLET [LEADIANT BIOSCIENCES, INC.]21Current NDC, Legacy NDC, 2 package rows20241114_d2133bc3-9c15-48bd-8b16-b8995a6a14cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206346Carnitor 330 MG Oral TabletPSNd2133bc3-9c15-48bd-8b16-b8995a6a14cd21
197448levOCARNitine 330 MG Oral TabletPSNd2133bc3-9c15-48bd-8b16-b8995a6a14cd21
206346levocarnitine 330 MG Oral Tablet [Carnitor]SBDd2133bc3-9c15-48bd-8b16-b8995a6a14cd21
197448levocarnitine 330 MG Oral TabletSCDd2133bc3-9c15-48bd-8b16-b8995a6a14cd21
206346Carnitor 330 MG Oral TabletSYd2133bc3-9c15-48bd-8b16-b8995a6a14cd21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54482-144-075448201440710 BLISTER PACK in 1 CARTON (54482-144-07) / 9 TABLET in 1 BLISTER PACK10 blister pack1985-12-270000-00-00NoNoCurrent