Levetiracetam

Product NDC
42254-056
11-digit product format
422540056
Labeler code
42254
Product ID
42254-056_eb02779c-acdc-48ed-9d23-ca39ba152d0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA078526
Marketing category
ANDA
Marketing start
2011-09-01
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
500 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-056-302019-09-24C16284748780-19350213a-3c5f-c013-e053-90daa90a1393Levetiracetam
42254-056-602019-09-24C16284748780-19350213a-3c5f-c013-e053-90daa90a1393Levetiracetam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-056-30Levetiracetam30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
42254-056-60Levetiracetam60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-056-30EA - Each42254-056e5a0b7fc-03a4-4b79-a79b-c81941e64b7c12012-07-24
42254-056-60EA - Each42254-0564a75c178-aa19-4d62-8392-4ab1f8061fc012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-056LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20120316_eb02779c-acdc-48ed-9d23-ca39ba152d0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSNeb02779c-acdc-48ed-9d23-ca39ba152d0d1
311289levetiracetam 500 MG Oral TabletSCDeb02779c-acdc-48ed-9d23-ca39ba152d0d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-056-304225400563030 in 1 BOTTLE, PLASTICHistorical
42254-056-604225400566060 in 1 BOTTLE, PLASTICHistorical