Levetiracetam

Product NDC
68001-405
11-digit product format
680010405
Labeler code
68001
Product ID
68001-405_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
1000 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
LEVETIRACETAM1000 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
68001-405-06Levetiracetam60 in 1 BOTTLETABLET, FILM COATED608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-405-06EA - Each68001-405c1c27d52-b375-4531-85cd-70af2d6b9d0912019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-405LEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]8Current NDC, Legacy NDC, 1 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
387003levETIRAcetam 1000 MG Oral TabletPSN031a32e1-675a-4efe-a66b-40beb4fe51012
311289levETIRAcetam 500 MG Oral TabletPSN031a32e1-675a-4efe-a66b-40beb4fe51012
387003levetiracetam 1000 MG Oral TabletSCD031a32e1-675a-4efe-a66b-40beb4fe51012
311289levetiracetam 500 MG Oral TabletSCD031a32e1-675a-4efe-a66b-40beb4fe51012
387003levETIRAcetam 1000 MG Oral TabletPSN51b66893-f7d6-8f9d-e063-6294a90a8e9b1
387003levetiracetam 1000 MG Oral TabletSCD51b66893-f7d6-8f9d-e063-6294a90a8e9b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-405-066800104050660 TABLET, FILM COATED in 1 BOTTLE (68001-405-06) 2019-06-190000-00-00NoNoCurrent