FDA.reportPublic FDA data

Levetiracetam

Product NDC
50090-7521
11-digit product format
500907521
Labeler code
50090
Product ID
50090-7521_48d58ab4-2d5c-4ac2-a2f3-a8b5163f0f28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091491
Marketing category
ANDA
Marketing start
2023-05-01
Substance
LEVETIRACETAM
Active strength
500 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
LEVETIRACETAM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui311289

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
50090-7521-0Levetiracetam120 in 1 BOTTLETABLET1201
50090-7521-1Levetiracetam60 in 1 BOTTLETABLET601
50090-7521-2Levetiracetam90 in 1 BOTTLETABLET901
50090-7521-3Levetiracetam180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7521-0EA - Each50090-75217a831f7d-656f-4bde-aa4c-6de37614ced812025-05-14
50090-7521-1EA - Each50090-7521bf088b24-3b91-4b2c-8ac1-bf2a105071ca12025-05-14
50090-7521-2EA - Each50090-7521acc768a1-8718-42d4-af73-48c139eaa60a12025-05-14
50090-7521-3EA - Each50090-752110328a84-be37-4110-8100-f20336b6b66412025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7521LEVETIRACETAM TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 4 package rows20250321_c82313cb-744f-45ef-b74c-1bdd055b2193.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSNc82313cb-744f-45ef-b74c-1bdd055b21931
311289levetiracetam 500 MG Oral TabletSCDc82313cb-744f-45ef-b74c-1bdd055b21931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7521-050090752100120 TABLET in 1 BOTTLE (50090-7521-0) 120 tablet2025-03-17NoNoHistorical
50090-7521-15009075210160 TABLET in 1 BOTTLE (50090-7521-1) 60 tablet2025-03-17NoNoHistorical
50090-7521-25009075210290 TABLET in 1 BOTTLE (50090-7521-2) 90 tablet2025-03-17NoNoHistorical
50090-7521-350090752103180 TABLET in 1 BOTTLE (50090-7521-3) 180 tablet2025-03-17NoNoHistorical