FDA.reportPublic FDA data

Levetiracetam

Product NDC
50090-6378
11-digit product format
500906378
Labeler code
50090
Product ID
50090-6378_a0b51ece-73dc-4060-9f61-d19ba7afa588
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090025
Marketing category
ANDA
Marketing start
2009-01-15
Substance
LEVETIRACETAM
Active strength
1000 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levetiracetam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui387003

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
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
50090-6378-0Levetiracetam30 in 1 BOTTLETABLET, FILM COATED306
50090-6378-1Levetiracetam60 in 1 BOTTLETABLET, FILM COATED606
50090-6378-2Levetiracetam180 in 1 BOTTLETABLET, FILM COATED1806

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6378-0EA - Each50090-6378927b437e-0684-4ca0-b3b0-bb0c2520369312023-04-07
50090-6378-1EA - Each50090-6378d17f7647-72d7-435a-83e1-0e9c7c0ee99312023-04-07
50090-6378-2EA - Each50090-6378ed577966-3e1c-4167-90d5-06a9d385266d12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6378LEVETIRACETAM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Current NDC, 3 package rows20240501_02e237ff-a3e0-40fe-a3d0-9d8802855c71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN02e237ff-a3e0-40fe-a3d0-9d8802855c716
387003levetiracetam 1000 MG Oral TabletSCD02e237ff-a3e0-40fe-a3d0-9d8802855c716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6378-05009063780030 TABLET, FILM COATED in 1 BOTTLE (50090-6378-0) 2023-02-22NoNoHistorical
50090-6378-15009063780160 TABLET, FILM COATED in 1 BOTTLE (50090-6378-1) 2023-02-22NoNoHistorical
50090-6378-250090637802180 TABLET, FILM COATED in 1 BOTTLE (50090-6378-2) 2023-02-22NoNoHistorical