Levocarnitine

Product NDC
64980-503
11-digit product format
649800503
Labeler code
64980
Product ID
64980-503_3beded34-64c8-4a1d-80d4-02b3007233b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocarnitine
Dosage form
SOLUTION
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA076851
Marketing category
ANDA
Marketing start
2004-09-20
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
4585a4fb-0028-3d95-020c-9b1c40bf15e0Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-503-12Levocarnitine118 mL in 1 BOTTLE, PLASTICSOLUTION1189

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-503-12ML - Milliliter64980-503be136d9e-5853-416c-bcff-874ca6ff58bb12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-503LEVOCARNITINE SOLUTION [RISING PHARMA HOLDINGS, INC.]8Current NDC, Legacy NDC, 1 package rows20241025_ada35959-e317-4161-ae79-3475096c679f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315134levOCARNitine 1 GM in 10 mL Oral SolutionPSNada35959-e317-4161-ae79-3475096c679f9
315134levocarnitine 100 MG/ML Oral SolutionSCDada35959-e317-4161-ae79-3475096c679f9
315134levocarnitine 1 GM per 10 ML Oral SolutionSYada35959-e317-4161-ae79-3475096c679f9
315134levocarnitine 10 % Oral SolutionSYada35959-e317-4161-ae79-3475096c679f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-503-1264980050312118 mL in 1 BOTTLE, PLASTIC (64980-503-12) 118 ml2004-09-200000-00-00NoNoCurrent