Levocarnitine

Product NDC
70954-139
11-digit product format
709540139
Labeler code
70954
Product ID
70954-139_83851536-e1cf-4353-af71-abe714a48c9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocarnitine
Dosage form
SOLUTION
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA211676
Marketing category
ANDA
Marketing start
2019-08-14
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
70954-139-10Levocarnitine118 mL in 1 BOTTLESOLUTION1187

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-139-10ML - Milliliter70954-1397a9461ff-4e3c-4878-af14-34b6fc2d288312019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-139LEVOCARNITINE SOLUTION [ANI PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 1 package rows20240522_18dc8eae-56c1-46ec-9d21-e17d7b2f91db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315134levOCARNitine 1 GM in 10 mL Oral SolutionPSN18dc8eae-56c1-46ec-9d21-e17d7b2f91db7
315134levocarnitine 100 MG/ML Oral SolutionSCD18dc8eae-56c1-46ec-9d21-e17d7b2f91db7
315134levocarnitine 1 GM per 10 ML Oral SolutionSY18dc8eae-56c1-46ec-9d21-e17d7b2f91db7
315134levocarnitine 10 % Oral SolutionSY18dc8eae-56c1-46ec-9d21-e17d7b2f91db7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-139-1070954013910118 mL in 1 BOTTLE (70954-139-10) 118 ml2019-08-140000-00-00NoNoCurrent