FDA.reportPublic FDA data

Levocarnitine

Product NDC
50383-171
11-digit product format
503830171
Labeler code
50383
Product ID
50383-171_60d74bef-d602-4750-90ea-5b0eab02555e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocarnitine
Dosage form
SOLUTION
Route
ORAL
Labeler
Akorn
Application
NDA019257
Marketing category
NDA
Marketing start
1986-04-10
Marketing end
0000-00-00
Substance
LEVOCARNITINE
Active strength
1 g/10mL
Pharmacologic classes
Carnitine Analog [EPC], Carnitine [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50383-171IInactivated by FDA2026-07-31
excluded packagepackage50383-17150383-171-04IInactivated by FDA2026-07-31

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
N019257-001CARNITORLEVOCARNITINE1GM/10MLSOLUTION / ORALAARLD, RS1986-04-10
N019257-002CARNITOR SFLEVOCARNITINE1GM/10MLSOLUTION / ORALAARLD2007-03-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N019257-001AA
N019257-002AA

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 22:54:322026-06N019257-001CARNITOR1GM/10MLSOLUTION / ORALAARLD, RS1986-04-10a50c72e98297…
2026-08-01 22:54:322026-06N019257-002CARNITOR SF1GM/10MLSOLUTION / ORALAARLD2007-03-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N019257-001AA1a50c72e98297…
2026-08-01 22:54:322026-06N019257-002AA1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carnitor SFLEVOCARNITINELeadiant Biosciences, Inc.dd904490-83f3-4cd3-bb6f-68e28509b4b62024-11-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 019257
application number: NDA019257
CarnitorLEVOCARNITINELeadiant Biosciences, Inc.b2cbc620-59fd-47b6-9e4b-7e3e31533a1c2024-01-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 019257
application number: NDA019257

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-171-042024-01-30C16284748780-11030e365-1f8b-111a-e063-dadaa90a10e2Levocarnitine Oral Solution, USP (1 g per 10 mL multidose)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-171-04Levocarnitine118 mL in 1 BOTTLESOLUTION1188

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-171-04ML - Milliliter50383-1716da1f574-347c-4f48-8fde-64384dd99e8012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOCARNITINEACTIVE INGREDIENT0G389FZZ9MLEVOCARNITINE SOLUTION [HI-TECH PHARMACAL CO., INC.]1
LEVOCARNITINEACTIVE MOIETY0G389FZZ9MLEVOCARNITINE SOLUTION [HI-TECH PHARMACAL CO., INC.]1
CHERRYINACTIVE INGREDIENTBUC5I9595WLEVOCARNITINE SOLUTION [HI-TECH PHARMACAL CO., INC.]1
MALIC ACIDINACTIVE INGREDIENT817L1N4CKPLEVOCARNITINE SOLUTION [HI-TECH PHARMACAL CO., INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLEVOCARNITINE SOLUTION [HI-TECH PHARMACAL CO., INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLEVOCARNITINE SOLUTION [HI-TECH PHARMACAL CO., INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554LEVOCARNITINE SOLUTION [HI-TECH PHARMACAL CO., INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RLEVOCARNITINE SOLUTION [HI-TECH PHARMACAL CO., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-171LEVOCARNITINE SOLUTION [AKORN]8Legacy NDC, 1 package rows20221116_3563c2f5-9814-4d55-8d90-bd7d6dcff36b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315134levOCARNitine 1 GM in 10 mL Oral SolutionPSN3563c2f5-9814-4d55-8d90-bd7d6dcff36b8
315134levocarnitine 100 MG/ML Oral SolutionSCD3563c2f5-9814-4d55-8d90-bd7d6dcff36b8
315134levocarnitine 1 GM per 10 ML Oral SolutionSY3563c2f5-9814-4d55-8d90-bd7d6dcff36b8
315134levocarnitine 10 % Oral SolutionSY3563c2f5-9814-4d55-8d90-bd7d6dcff36b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-171-0450383017104118 mL in 1 BOTTLE (50383-171-04) 118 ml2007-10-250000-00-00NoNoCurrent