FDA.reportPublic FDA data

Levetiracetam

Product NDC
0615-8499
11-digit product format
006158499
Labeler code
0615
Product ID
0615-8499_8d4105d5-1eda-42d1-b232-34b8b189e63a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA214815
Marketing category
ANDA
Marketing start
2022-10-07
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
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
0615-8499-05Levetiracetam15 in 1 BLISTER PACKTABLET, FILM COATED157
0615-8499-28Levetiracetam28 in 1 BLISTER PACKTABLET, FILM COATED287
0615-8499-30Levetiracetam6 in 1 BOX, UNIT-DOSETABLET, FILM COATED67
0615-8499-30Levetiracetam5 in 1 BLISTER PACKTABLET, FILM COATED57
0615-8499-39Levetiracetam30 in 1 BLISTER PACKTABLET, FILM COATED307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8499LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]6Current NDC, 5 package rows20250119_dfb7c640-623e-43d1-8ee8-479dccd53d0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSNdfb7c640-623e-43d1-8ee8-479dccd53d0a7
311288levETIRAcetam 250 MG Oral TabletPSNdfb7c640-623e-43d1-8ee8-479dccd53d0a7
311289levETIRAcetam 500 MG Oral TabletPSNdfb7c640-623e-43d1-8ee8-479dccd53d0a7
311290levETIRAcetam 750 MG Oral TabletPSNdfb7c640-623e-43d1-8ee8-479dccd53d0a7
387003levetiracetam 1000 MG Oral TabletSCDdfb7c640-623e-43d1-8ee8-479dccd53d0a7
311288levetiracetam 250 MG Oral TabletSCDdfb7c640-623e-43d1-8ee8-479dccd53d0a7
311289levetiracetam 500 MG Oral TabletSCDdfb7c640-623e-43d1-8ee8-479dccd53d0a7
311290levetiracetam 750 MG Oral TabletSCDdfb7c640-623e-43d1-8ee8-479dccd53d0a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8499-050061584990515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8499-05) 2024-01-11NoNoHistorical
0615-8499-280061584992828 TABLET, FILM COATED in 1 BLISTER PACK (0615-8499-28) 2025-01-10NoNoHistorical
0615-8499-30006158499306 in 1 BOX, UNIT-DOSEHistorical
0615-8499-390061584993930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8499-39) 2024-01-11NoNoHistorical