FDA.reportPublic FDA data

Levetiracetam

Product NDC
50090-2875
11-digit product format
500902875
Labeler code
50090
Product ID
50090-2875_b9dfd326-74eb-49b7-bfdf-0d3364623536
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090515
Marketing category
ANDA
Marketing start
2010-10-08
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
Rxcui311289, 387003

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2875-0Levetiracetam30 in 1 BOTTLETABLET, FILM COATED3036
50090-2875-1Levetiracetam60 in 1 BOTTLETABLET, FILM COATED6036
50090-2875-2Levetiracetam180 in 1 BOTTLETABLET, FILM COATED18036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2875-0EA - Each50090-28758914d721-56e6-4e93-9a13-bc010ec1812f12019-04-11
50090-2875-1EA - Each50090-2875d5f7ec99-2eb4-4017-9ae9-80f6d29f247512022-12-07
50090-2875-2EA - Each50090-2875405b09b5-1f84-4b34-91b0-c5bfd0e3538d12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2875LEVETIRACETAM (LEVETIRACETAM) TABLET, FILM COATED LEVETIRACETAM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]33Current NDC, Legacy NDC, 3 package rows20250516_b9597cd5-5745-494a-bd72-93071ed221da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSNb9597cd5-5745-494a-bd72-93071ed221da36
311289levETIRAcetam 500 MG Oral TabletPSNb9597cd5-5745-494a-bd72-93071ed221da36
387003levetiracetam 1000 MG Oral TabletSCDb9597cd5-5745-494a-bd72-93071ed221da36
311289levetiracetam 500 MG Oral TabletSCDb9597cd5-5745-494a-bd72-93071ed221da36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2875-05009028750030 TABLET, FILM COATED in 1 BOTTLE (50090-2875-0) 2017-02-170000-00-00NoNoCurrent
50090-2875-15009028750160 TABLET, FILM COATED in 1 BOTTLE (50090-2875-1) 2022-03-150000-00-00NoNoCurrent
50090-2875-250090287502180 TABLET, FILM COATED in 1 BOTTLE (50090-2875-2) 2022-03-090000-00-00NoNoCurrent