FDA.reportPublic FDA data

Levetiracetam

Product NDC
0904-7123
11-digit product format
009047123
Labeler code
0904
Product ID
0904-7123_4545f425-4930-4df2-b58b-8b20bb9edfb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA078993
Marketing category
ANDA
Marketing start
2009-01-15
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

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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
0904-7123-61Levetiracetam100 in 1 CARTONTABLET, FILM COATED1004
0904-7123-61Levetiracetam1 in 1 BLISTER PACKTABLET, FILM COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7123-61EA - Each0904-7123f7cf420e-80d1-4c05-88ee-49ba0c4679d912021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7123LEVETIRACETAM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 2 package rows20241122_c4b27429-50a3-467c-a5ff-7e49a01a1088.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311288levETIRAcetam 250 MG Oral TabletPSN0348fec4-d919-4307-ac90-35360819bc006
311289levETIRAcetam 500 MG Oral TabletPSN0348fec4-d919-4307-ac90-35360819bc006
311288levetiracetam 250 MG Oral TabletSCD0348fec4-d919-4307-ac90-35360819bc006
311289levetiracetam 500 MG Oral TabletSCD0348fec4-d919-4307-ac90-35360819bc006
311288levETIRAcetam 250 MG Oral TabletPSNc4b27429-50a3-467c-a5ff-7e49a01a10884
311289levETIRAcetam 500 MG Oral TabletPSNc4b27429-50a3-467c-a5ff-7e49a01a10884
311290levETIRAcetam 750 MG Oral TabletPSNc4b27429-50a3-467c-a5ff-7e49a01a10884
311288levetiracetam 250 MG Oral TabletSCDc4b27429-50a3-467c-a5ff-7e49a01a10884
311289levetiracetam 500 MG Oral TabletSCDc4b27429-50a3-467c-a5ff-7e49a01a10884
311290levetiracetam 750 MG Oral TabletSCDc4b27429-50a3-467c-a5ff-7e49a01a10884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7123-6100904712361100 BLISTER PACK in 1 CARTON (0904-7123-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2009-01-150000-00-00NoNoCurrent