FDA.reportPublic FDA data

Levocarnitine

Product NDC
0143-9852
11-digit product format
001439852
Labeler code
0143
Product ID
0143-9852_1bc5a420-8884-4b82-a39b-02064a59fde4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocarnitine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA075567
Marketing category
ANDA
Marketing start
2023-06-01
Substance
LEVOCARNITINE
Active strength
1 g/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0G389FZZ9M
Rxcui1791371

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
0143-9852-01Levocarnitine5 mL in 1 VIAL, SINGLE-USEINJECTION56
0143-9852-10Levocarnitine10 in 1 CARTONINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9852-01ML - Milliliter0143-98529873c08d-6c0c-4ec0-9392-4e909fb9231312023-10-16
0143-9852-10ML - Milliliter0143-98528af5966c-346c-4282-be7d-bdf4575087de12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9852LEVOCARNITINE INJECTION [HIKMA PHARMACEUTICALS USA INC.]6Current NDC, 2 package rows20230602_8f255df8-8a1f-4b4f-ae8c-2c80532ce8d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791371levOCARNitine 1 GM in 5 ML InjectionPSN8f255df8-8a1f-4b4f-ae8c-2c80532ce8d46
17913715 ML levocarnitine 200 MG/ML InjectionSCD8f255df8-8a1f-4b4f-ae8c-2c80532ce8d46
1791371levocarnitine 1 GM per 5 ML InjectionSY8f255df8-8a1f-4b4f-ae8c-2c80532ce8d46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9852-01001439852015 mL in 1 VIAL, SINGLE-USE5 mlHistorical
0143-9852-100014398521010 VIAL, SINGLE-USE in 1 CARTON (0143-9852-10) / 5 mL in 1 VIAL, SINGLE-USE (0143-9852-01) 2023-06-01NoNoHistorical