Levetiracetam

Product NDC
43547-224
11-digit product format
435470224
Labeler code
43547
Product ID
43547-224_da6c3e56-5044-4f0b-9f0e-7267e2fe89bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA078106
Marketing category
ANDA
Marketing start
2012-09-11
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
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
43547-224-06Levetiracetam60 in 1 BOTTLETABLET, FILM COATED6020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-224LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]20Current NDC, Legacy NDC, 1 package rows20240420_dd713e60-478c-43cd-b680-ff594a0b3864.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSNdd713e60-478c-43cd-b680-ff594a0b386420
311288levETIRAcetam 250 MG Oral TabletPSNdd713e60-478c-43cd-b680-ff594a0b386420
311289levETIRAcetam 500 MG Oral TabletPSNdd713e60-478c-43cd-b680-ff594a0b386420
311290levETIRAcetam 750 MG Oral TabletPSNdd713e60-478c-43cd-b680-ff594a0b386420
387003levetiracetam 1000 MG Oral TabletSCDdd713e60-478c-43cd-b680-ff594a0b386420
311288levetiracetam 250 MG Oral TabletSCDdd713e60-478c-43cd-b680-ff594a0b386420
311289levetiracetam 500 MG Oral TabletSCDdd713e60-478c-43cd-b680-ff594a0b386420
311290levetiracetam 750 MG Oral TabletSCDdd713e60-478c-43cd-b680-ff594a0b386420
387003levETIRAcetam 1000 MG Oral TabletPSNe836e455-e1c0-482e-8d00-5be150399e086
387003levetiracetam 1000 MG Oral TabletSCDe836e455-e1c0-482e-8d00-5be150399e086
387003levETIRAcetam 1000 MG Oral TabletPSNed8e88d0-993e-4683-bdcf-31578130d3df5
387003levetiracetam 1000 MG Oral TabletSCDed8e88d0-993e-4683-bdcf-31578130d3df5
387003levETIRAcetam 1000 MG Oral TabletPSN4f96d083-06a7-3655-e054-00144ff8d46c4
387003levetiracetam 1000 MG Oral TabletSCD4f96d083-06a7-3655-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-224-064354702240660 TABLET, FILM COATED in 1 BOTTLE (43547-224-06) 2012-09-110000-00-00NoNoCurrent