FDA.reportPublic FDA data

Levocarnitine

Product NDC
71656-016
11-digit product format
716560016
Labeler code
71656
Product ID
71656-016_30a343cc-caab-d417-e063-6394a90ad77b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocarnitine Oral
Dosage form
SOLUTION
Route
ORAL
Labeler
Saptalis Pharmaceuticals, LLC
Application
ANDA212533
Marketing category
ANDA
Marketing start
2024-02-21
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
71656-016-01Levocarnitine100 in 1 TRAYSOLUTION1004
71656-016-02Levocarnitine100 in 1 TRAYSOLUTION1004
71656-016-04Levocarnitine118 mL in 1 BOTTLESOLUTION1184
71656-016-05Levocarnitine5 mL in 1 CUP, UNIT-DOSESOLUTION54
71656-016-10Levocarnitine10 mL in 1 CUP, UNIT-DOSESOLUTION104
71656-016-50Levocarnitine50 in 1 TRAYSOLUTION504
71656-016-51Levocarnitine50 in 1 TRAYSOLUTION504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71656-016-05ML - Milliliter71656-016fc6441ba-e21f-49da-8ca4-669ba856243c12025-05-14
71656-016-10ML - Milliliter71656-01607fcff02-d4ca-44ca-a406-e7fa20d89b3c12025-05-14
71656-016-50ML - Milliliter71656-01626094113-64d4-4ed4-b8cd-2f6e52a602ec12024-02-14
71656-016-51ML - Milliliter71656-016860c8eb6-ab29-4100-981e-6a255bd3243012024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71656-016LEVOCARNITINE (LEVOCARNITINE ORAL) SOLUTION [SAPTALIS PHARMACEUTICALS, LLC]4Current NDC, 7 package rows20250321_75b43fb1-4486-48a0-b571-7754dce350a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315134levOCARNitine 1 GM in 10 mL Oral SolutionPSN75b43fb1-4486-48a0-b571-7754dce350a34
315134levocarnitine 100 MG/ML Oral SolutionSCD75b43fb1-4486-48a0-b571-7754dce350a34
315134levocarnitine 1 GM per 10 ML Oral SolutionSY75b43fb1-4486-48a0-b571-7754dce350a34
315134levocarnitine 10 % Oral SolutionSY75b43fb1-4486-48a0-b571-7754dce350a34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71656-016-0171656001601100 CUP, UNIT-DOSE in 1 TRAY (71656-016-01) / 5 mL in 1 CUP, UNIT-DOSE (71656-016-05) 2024-02-21NoNoCurrent
71656-016-0271656001602100 CUP, UNIT-DOSE in 1 TRAY (71656-016-02) / 10 mL in 1 CUP, UNIT-DOSE (71656-016-10) 2024-02-21NoNoCurrent
71656-016-0471656001604118 mL in 1 BOTTLE (71656-016-04) 118 ml2024-02-21NoNoCurrent
71656-016-05716560016055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
71656-016-107165600161010 mL in 1 CUP, UNIT-DOSE10 mlHistorical
71656-016-507165600165050 CUP, UNIT-DOSE in 1 TRAY (71656-016-50) / 5 mL in 1 CUP, UNIT-DOSE (71656-016-05) 2024-02-21NoNoCurrent
71656-016-517165600165150 CUP, UNIT-DOSE in 1 TRAY (71656-016-51) / 10 mL in 1 CUP, UNIT-DOSE (71656-016-10) 2024-02-21NoNoCurrent