Levocarnitine

Product NDC
16571-762
11-digit product format
165710762
Labeler code
16571
Product ID
16571-762_ad6d92d4-71c1-481a-a7cf-b2d551c5daad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocarnitine
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA076858
Marketing category
ANDA
Marketing start
2020-12-01
Substance
LEVOCARNITINE
Active strength
330 mg/1
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
LEVOCARNITINE330 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0G389FZZ9M
Rxcui197448

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
16571-762-09Levocarnitine9 in 1 CARTONTABLET93
16571-762-09Levocarnitine10 in 1 BLISTER PACKTABLET103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-762-09EA - Each16571-7624b3a0ccb-29b0-4a4a-86a8-481691eaebe412023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-762LEVOCARNITINE TABLET [RISING PHARMA HOLDINGS, INC.]3Current NDC, 2 package rows20240927_0f749812-8f02-4eeb-91d9-5dd6fc9fa159.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197448levOCARNitine 330 MG Oral TabletPSN0f749812-8f02-4eeb-91d9-5dd6fc9fa1593
197448levocarnitine 330 MG Oral TabletSCD0f749812-8f02-4eeb-91d9-5dd6fc9fa1593

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16571-762-09165710762099 BLISTER PACK in 1 CARTON (16571-762-09) / 10 TABLET in 1 BLISTER PACK9 blister pack2020-12-01NoNoCurrent