FDA.reportPublic FDA data

LEVETIRACETAM

Product NDC
63629-9847
11-digit product format
636299847
Labeler code
63629
Product ID
63629-9847_cac0490d-b164-41d1-81f9-336c8cf1b5b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203468
Marketing category
ANDA
Marketing start
2014-05-01
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
Rxcui807832

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
63629-9847-1LEVETIRACETAM21 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE21101
63629-9847-2LEVETIRACETAM30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE30101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9847LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240724_ace53552-d616-45e8-9f99-2f0041d0b430.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
807832levETIRAcetam 500 MG 24HR Extended Release Oral TabletPSNace53552-d616-45e8-9f99-2f0041d0b430101
80783224 HR levetiracetam 500 MG Extended Release Oral TabletSCDace53552-d616-45e8-9f99-2f0041d0b430101
807832levetiracetam 500 MG 24 HR Extended Release Oral TabletSYace53552-d616-45e8-9f99-2f0041d0b430101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63629-9847-16362998470121 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9847-1) 2023-09-27NoNoHistorical
63629-9847-26362998470230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9847-2) 2024-07-09NoNoHistorical