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

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#

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