Levetiracetam

Product NDC
55154-5782
11-digit product format
551545782
Labeler code
55154
Product ID
55154-5782_402eff19-cfb5-4cde-a53c-2a73f78b468f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
SOLUTION
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA201157
Marketing category
ANDA
Marketing start
2015-06-04
Substance
LEVETIRACETAM
Active strength
500 mg/5mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levetiracetam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM500 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui403884

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-5782-5Levetiracetam5 in 1 BAGSOLUTION58
55154-5782-5Levetiracetam5 mL in 1 CUP, UNIT-DOSESOLUTION58

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-5782LEVETIRACETAM SOLUTION [CARDINAL HEALTH 107, LLC]8Current NDC, Legacy NDC, 2 package rows20250403_f924d55d-d7ec-4448-b54e-3a7eaf5a1cab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSNf924d55d-d7ec-4448-b54e-3a7eaf5a1cab8
403884levetiracetam 100 MG/ML Oral SolutionSCDf924d55d-d7ec-4448-b54e-3a7eaf5a1cab8
403884levetiracetam 100 MG per 1 ML Oral SolutionSYf924d55d-d7ec-4448-b54e-3a7eaf5a1cab8
403884levetiracetam 1000 MG per 10 ML Oral SolutionSYf924d55d-d7ec-4448-b54e-3a7eaf5a1cab8
403884levetiracetam 1500 MG per 15 ML Oral SolutionSYf924d55d-d7ec-4448-b54e-3a7eaf5a1cab8
403884levetiracetam 500 MG per 5 ML Oral SolutionSYf924d55d-d7ec-4448-b54e-3a7eaf5a1cab8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-5782-5551545782055 CUP, UNIT-DOSE in 1 BAG (55154-5782-5) / 5 mL in 1 CUP, UNIT-DOSE2015-06-040000-00-00NoNoCurrent