FDA.reportPublic FDA data

Levetiracetam

Product NDC
68001-402
11-digit product format
680010402
Labeler code
68001
Product ID
68001-402_28d8b606-37b2-642c-e063-6294a90ad080
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA078993
Marketing category
ANDA
Marketing start
2019-06-19
Substance
LEVETIRACETAM
Active strength
250 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
LEVETIRACETAM250 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-402-03Levetiracetam500 in 1 BOTTLETABLET, FILM COATED5008
68001-402-07Levetiracetam120 in 1 BOTTLETABLET, FILM COATED1208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-402-03EA - Each68001-402d4116703-bda2-4a84-bb23-53bdc1a42e1712019-09-05
68001-402-07EA - Each68001-4025a3d1d81-09a7-4b31-ac5e-0e3e0f10d7ba12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-402LEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]8Current NDC, Legacy NDC, 2 package rows20241213_8b74b8bc-d95c-4471-8f74-c3117243bf89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN8b74b8bc-d95c-4471-8f74-c3117243bf898
311288levETIRAcetam 250 MG Oral TabletPSN8b74b8bc-d95c-4471-8f74-c3117243bf898
311289levETIRAcetam 500 MG Oral TabletPSN8b74b8bc-d95c-4471-8f74-c3117243bf898
311290levETIRAcetam 750 MG Oral TabletPSN8b74b8bc-d95c-4471-8f74-c3117243bf898
387003levetiracetam 1000 MG Oral TabletSCD8b74b8bc-d95c-4471-8f74-c3117243bf898
311288levetiracetam 250 MG Oral TabletSCD8b74b8bc-d95c-4471-8f74-c3117243bf898
311289levetiracetam 500 MG Oral TabletSCD8b74b8bc-d95c-4471-8f74-c3117243bf898
311290levetiracetam 750 MG Oral TabletSCD8b74b8bc-d95c-4471-8f74-c3117243bf898
311288levETIRAcetam 250 MG Oral TabletPSN5037a86a-21f2-d793-e063-6394a90a2cb51
311288levetiracetam 250 MG Oral TabletSCD5037a86a-21f2-d793-e063-6394a90a2cb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-402-0368001040203500 TABLET, FILM COATED in 1 BOTTLE (68001-402-03) 2019-06-190000-00-00NoNoCurrent
68001-402-0768001040207120 TABLET, FILM COATED in 1 BOTTLE (68001-402-07) 2019-06-190000-00-00NoNoCurrent