Levetiracetam

Product NDC
71335-2098
11-digit product format
713352098
Labeler code
71335
Product ID
71335-2098_ae0d1db5-70f3-4bee-a96f-8bf52f12cea8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078154
Marketing category
ANDA
Marketing start
2009-01-15
Substance
LEVETIRACETAM
Active strength
750 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
LEVETIRACETAM750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui311290

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
71335-2098-1Levetiracetam30 in 1 BOTTLETABLET, FILM COATED30102
71335-2098-2Levetiracetam60 in 1 BOTTLETABLET, FILM COATED60102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2098LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 2 package rows20240420_90e01877-abcb-4697-a7ed-9afe5ee77050.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311290levETIRAcetam 750 MG Oral TabletPSN90e01877-abcb-4697-a7ed-9afe5ee77050102
311290levetiracetam 750 MG Oral TabletSCD90e01877-abcb-4697-a7ed-9afe5ee77050102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2098-17133520980130 TABLET, FILM COATED in 1 BOTTLE (71335-2098-1) 2022-05-200000-00-00NoNoCurrent
71335-2098-27133520980260 TABLET, FILM COATED in 1 BOTTLE (71335-2098-2) 2024-04-030000-00-00NoNoCurrent