FDA.reportPublic FDA data

Levocarnitine

Product NDC
0517-1075
11-digit product format
005171075
Labeler code
0517
Product ID
0517-1075_114eaeda-8965-4c92-a3ff-15021b305464
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocarnitine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
American Regent, Inc.
Application
ANDA075861
Marketing category
ANDA
Marketing start
2023-06-21
Substance
LEVOCARNITINE
Active strength
200 mg/mL
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
LEVOCARNITINE200 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0G389FZZ9M
Rxcui1791371, 2673428

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
0517-1075-01Levocarnitine20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2011
0517-1075-01Levocarnitine1 in 1 CARTONINJECTION, SOLUTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-1075-01ML - Milliliter0517-107586765cef-b840-4091-834c-12aef0dc056212024-02-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOCARNITINEACTIVE INGREDIENT0G389FZZ9MLEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]4
LEVOCARNITINEACTIVE MOIETY0G389FZZ9MLEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RLEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-1075LEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]11Current NDC, 2 package rows20240123_cc4da2c3-f939-444d-9b5b-a57b6051c190.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791371levOCARNitine 1 GM in 5 ML InjectionPSNcc4da2c3-f939-444d-9b5b-a57b6051c19011
2673428levOCARNitine 4 GM in 20 ML InjectionPSNcc4da2c3-f939-444d-9b5b-a57b6051c19011
267342820 ML levocarnitine 200 MG/ML InjectionSCDcc4da2c3-f939-444d-9b5b-a57b6051c19011
17913715 ML levocarnitine 200 MG/ML InjectionSCDcc4da2c3-f939-444d-9b5b-a57b6051c19011
1791371levocarnitine 1 GM per 5 ML InjectionSYcc4da2c3-f939-444d-9b5b-a57b6051c19011
2673428levocarnitine 4 GM per 20 ML InjectionSYcc4da2c3-f939-444d-9b5b-a57b6051c19011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0517-1075-01005171075011 VIAL, SINGLE-DOSE in 1 CARTON (0517-1075-01) / 20 mL in 1 VIAL, SINGLE-DOSE2023-06-21NoNoCurrent