FDA.reportPublic FDA data

Levocarnitine

Product NDC
50383-172
11-digit product format
503830172
Labeler code
50383
Product ID
50383-172_fab8a875-841f-496d-ba11-02593522599b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocarnitine
Dosage form
TABLET
Route
ORAL
Labeler
Akorn
Application
NDA018948
Marketing category
NDA
Marketing start
2005-11-01
Marketing end
0000-00-00
Substance
LEVOCARNITINE
Active strength
330 mg/1
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 productproduct50383-172IInactivated by FDA2026-07-31
excluded packagepackage50383-17250383-172-90IInactivated 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
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

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
50383-172-902024-01-30C16284748780-1d6a99b39-e3d8-a426-e053-dadaa90af4c2Levocarnitine Tablets USP (330 mg)
50383-172-902022-02-01C16284748780-1d6a99b39-e3d8-a426-e053-dadaa90af4c2Levocarnitine Tablets USP (330 mg)
50383-172-902022-01-28C16284748780-1d6a99b39-e3d8-a426-e053-dadaa90af4c2Levocarnitine Tablets USP (330 mg)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-172-90Levocarnitine10 in 1 BLISTER PACKTABLET106
50383-172-90Levocarnitine9 in 1 CARTONTABLET96

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-172-90EA - Each50383-172d42a6c2a-f4d8-4a65-ad9c-f536b075f32112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOCARNITINEACTIVE INGREDIENT0G389FZZ9MLEVOCARNITINE TABLET [HI-TECH PHARMACAL CO., INC.]1
LEVOCARNITINEACTIVE MOIETY0G389FZZ9MLEVOCARNITINE TABLET [HI-TECH PHARMACAL CO., INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOCARNITINE TABLET [HI-TECH PHARMACAL CO., INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOCARNITINE TABLET [HI-TECH PHARMACAL CO., INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ELEVOCARNITINE TABLET [HI-TECH PHARMACAL CO., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-172LEVOCARNITINE TABLET [AKORN]6Legacy NDC, 2 package rows20221111_c8a590a7-628b-45c5-ac2c-24214a69eaa6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197448levOCARNitine 330 MG Oral TabletPSNc8a590a7-628b-45c5-ac2c-24214a69eaa66
197448levocarnitine 330 MG Oral TabletSCDc8a590a7-628b-45c5-ac2c-24214a69eaa66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-172-90503830172909 BLISTER PACK in 1 CARTON (50383-172-90) > 10 TABLET in 1 BLISTER PACK9 blister pack2005-11-010000-00-00NoNoCurrent