Levetiracetam

Product NDC
55154-5699
11-digit product format
551545699
Labeler code
55154
Product ID
55154-5699_e56a8b10-ac51-4699-834b-55c14d96935c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA076919
Marketing category
ANDA
Marketing start
2012-08-29
Substance
LEVETIRACETAM
Active strength
500 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levetiracetam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui311289

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
55154-5699-0Levetiracetam10 in 1 BAGTABLET, FILM COATED1022
55154-5699-0Levetiracetam1 in 1 BLISTER PACKTABLET, FILM COATED122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-5699-0EA - Each55154-56999dacb06c-18a3-4b50-a002-ad4d964d3df512020-03-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH]9
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH]9
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH]9
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH]9
TRIACETININACTIVE INGREDIENTXHX3C3X673LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-5699LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]20Current NDC, Legacy NDC, 2 package rows20240927_e1b14939-7262-40dc-a334-2b3b72c88d47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSNe1b14939-7262-40dc-a334-2b3b72c88d4723
311289levetiracetam 500 MG Oral TabletSCDe1b14939-7262-40dc-a334-2b3b72c88d4723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-5699-05515456990010 BLISTER PACK in 1 BAG (55154-5699-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2012-08-290000-00-00NoNoCurrent