FDA.reportPublic FDA data

Levetiracetam

Product NDC
71335-0694
11-digit product format
713350694
Labeler code
71335
Product ID
71335-0694_0f1f4da7-f189-4638-a1ad-056e19185f61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090515
Marketing category
ANDA
Marketing start
2010-10-08
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0694-1Levetiracetam90 in 1 BOTTLETABLET, FILM COATED906
71335-0694-2Levetiracetam60 in 1 BOTTLETABLET, FILM COATED606
71335-0694-3Levetiracetam30 in 1 BOTTLETABLET, FILM COATED306
71335-0694-4Levetiracetam120 in 1 BOTTLETABLET, FILM COATED1206
71335-0694-5Levetiracetam28 in 1 BOTTLETABLET, FILM COATED286
71335-0694-6Levetiracetam100 in 1 BOTTLETABLET, FILM COATED1006
71335-0694-7Levetiracetam21 in 1 BOTTLETABLET, FILM COATED216

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0694LEVETIRACETAM (LEVETIRACETAM) TABLET, FILM COATED LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 7 package rows20240601_adbcb0f7-0421-47e2-854e-e1cfefb6386f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311288levETIRAcetam 250 MG Oral TabletPSNadbcb0f7-0421-47e2-854e-e1cfefb6386f6
311289levETIRAcetam 500 MG Oral TabletPSNadbcb0f7-0421-47e2-854e-e1cfefb6386f6
311288levetiracetam 250 MG Oral TabletSCDadbcb0f7-0421-47e2-854e-e1cfefb6386f6
311289levetiracetam 500 MG Oral TabletSCDadbcb0f7-0421-47e2-854e-e1cfefb6386f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0694-17133506940190 TABLET, FILM COATED in 1 BOTTLE (71335-0694-1) 2018-03-090000-00-00NoNoCurrent
71335-0694-27133506940260 TABLET, FILM COATED in 1 BOTTLE (71335-0694-2) 2018-02-160000-00-00NoNoCurrent
71335-0694-37133506940330 TABLET, FILM COATED in 1 BOTTLE (71335-0694-3) 2019-02-070000-00-00NoNoCurrent
71335-0694-471335069404120 TABLET, FILM COATED in 1 BOTTLE (71335-0694-4) 2019-03-060000-00-00NoNoCurrent
71335-0694-57133506940528 TABLET, FILM COATED in 1 BOTTLE (71335-0694-5) 2024-05-290000-00-00NoNoCurrent
71335-0694-671335069406100 TABLET, FILM COATED in 1 BOTTLE (71335-0694-6) 2024-05-29NoNoCurrent
71335-0694-77133506940721 TABLET, FILM COATED in 1 BOTTLE (71335-0694-7) 2024-05-29NoNoCurrent