FDA.reportPublic FDA data

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018948-001CARNITORLEVOCARNITINE330MGTABLET / ORALABRLD, RS1985-12-27
N018948-002CARNITORLEVOCARNITINE1GM/10MLSOLUTION / ORAL1988-04-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N018948-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N018948-001CARNITOR330MGTABLET / ORALABRLD, RS1985-12-27a50c72e98297…
2026-08-01 22:54:322026-06N018948-002CARNITOR1GM/10MLSOLUTION / ORAL1988-04-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N018948-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CARNITORLEVOCARNITINELeadiant Biosciences, Inc.d2133bc3-9c15-48bd-8b16-b8995a6a14cd2024-10-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 018948
application number: NDA018948
ndc (product): 54482-144

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0G389FZZ9MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197448Internal RxNorm lookup
206346Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d2133bc3-9c15-48bd-8b16-b8995a6a14cdAvailable on FDA.report

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