FDA.reportPublic FDA data

Levetiracetam

Product NDC
76494-529
11-digit product format
764940529
Labeler code
76494
Product ID
76494-529_bf716ab6-d438-4a19-8193-dbc05b4eabad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Prinston Pharmaceutical Inc.
Application
ANDA078106
Marketing category
ANDA
Marketing start
2012-09-11
Substance
LEVETIRACETAM
Active strength
500 mg/1
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/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui311288, 311289, 311290, 387003

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
76494-529-122020-08-25C16284748780-19d75b9d0-5a91-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Levetiracetam Tablets safely and effectively. See full prescribing information for levetiracetam tablets. Levetiracetam Tablets, USP, film coated for oral use Initial U.S. Approval: 1999
76494-529-122020-01-31C16284748780-19d75b9d0-5a91-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Levetiracetam Tablets safely and effectively. See full prescribing information for levetiracetam tablets. Levetiracetam Tablets, USP, film coated for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76494-529-12Levetiracetam120 in 1 BOTTLETABLET, FILM COATED12012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KLEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NLEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
POLYETHYLENE GLYCOL 800INACTIVE INGREDIENTUH6KR4953DLEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
TRIACETININACTIVE INGREDIENTXHX3C3X673LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76494-529LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]12Current NDC, Legacy NDC, 1 package rows20200826_d818ef84-9b3e-434b-92d9-910cfa8af7da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSNd818ef84-9b3e-434b-92d9-910cfa8af7da12
311288levETIRAcetam 250 MG Oral TabletPSNd818ef84-9b3e-434b-92d9-910cfa8af7da12
311289levETIRAcetam 500 MG Oral TabletPSNd818ef84-9b3e-434b-92d9-910cfa8af7da12
311290levETIRAcetam 750 MG Oral TabletPSNd818ef84-9b3e-434b-92d9-910cfa8af7da12
387003levetiracetam 1000 MG Oral TabletSCDd818ef84-9b3e-434b-92d9-910cfa8af7da12
311288levetiracetam 250 MG Oral TabletSCDd818ef84-9b3e-434b-92d9-910cfa8af7da12
311289levetiracetam 500 MG Oral TabletSCDd818ef84-9b3e-434b-92d9-910cfa8af7da12
311290levetiracetam 750 MG Oral TabletSCDd818ef84-9b3e-434b-92d9-910cfa8af7da12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76494-529-1276494052912120 TABLET, FILM COATED in 1 BOTTLE (76494-529-12) 2012-09-110000-00-00NoNoCurrent