Levocarnitine

Product NDC
52817-830
11-digit product format
528170830
Labeler code
52817
Product ID
52817-830_2a4543d7-2fcf-548c-e063-6394a90af66e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocarnitine
Dosage form
SOLUTION
Route
ORAL
Labeler
TRUPHARMA, LLC
Application
ANDA212533
Marketing category
ANDA
Marketing start
2022-02-09
Substance
LEVOCARNITINE
Active strength
1 g/10mL
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
Levocarnitine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOCARNITINE1 g/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0G389FZZ9M
Rxcui315134

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
08c722ec-780f-bb7b-8f14-3d4f7bf0e098Product name220240205
e2f276e5-439f-b432-b5e5-b0cfa993da69Product name320220609
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
4585a4fb-0028-3d95-020c-9b1c40bf15e0Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52817-830-04Levocarnitine118 mL in 1 BOTTLESOLUTION1182

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-830-04ML - Milliliter52817-830df3adea7-d241-4690-9021-c803e87bca1312022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-830LEVOCARNITINE SOLUTION [TRUPHARMA, LLC]2Current NDC, Legacy NDC, 1 package rows20241228_05ab18c1-fb01-48fa-8f05-0200bb8a5edf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315134levOCARNitine 1 GM in 10 mL Oral SolutionPSN05ab18c1-fb01-48fa-8f05-0200bb8a5edf2
315134levocarnitine 100 MG/ML Oral SolutionSCD05ab18c1-fb01-48fa-8f05-0200bb8a5edf2
315134levocarnitine 1 GM per 10 ML Oral SolutionSY05ab18c1-fb01-48fa-8f05-0200bb8a5edf2
315134levocarnitine 10 % Oral SolutionSY05ab18c1-fb01-48fa-8f05-0200bb8a5edf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-830-0452817083004118 mL in 1 BOTTLE (52817-830-04) 118 ml2022-02-090000-00-00NoNoCurrent