Levocarnitine

Product NDC
70954-492
11-digit product format
709540492
Labeler code
70954
Product ID
70954-492_d259f663-b597-48bd-8420-3b5774ffc204
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocarnitine
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA216384
Marketing category
ANDA
Marketing start
2022-12-09
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
70954-492-10Levocarnitine10 in 1 BLISTER PACKTABLET104
70954-492-10Levocarnitine90 in 1 CARTONTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-492-10EA - Each70954-4928b1ce435-ab11-496a-81e5-5698d4b13d3a12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-492LEVOCARNITINE TABLET [ANI PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20230922_bfd0d39f-d3b2-4f0d-b7a2-071a545900f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197448levOCARNitine 330 MG Oral TabletPSNbfd0d39f-d3b2-4f0d-b7a2-071a545900f44
197448levocarnitine 330 MG Oral TabletSCDbfd0d39f-d3b2-4f0d-b7a2-071a545900f44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-492-107095404921090 BLISTER PACK in 1 CARTON (70954-492-10) / 10 TABLET in 1 BLISTER PACK90 blister pack2022-12-090000-00-00NoNoCurrent