FDA.reportPublic FDA data

Levetiracetam

Product NDC
50405-300
11-digit product format
504050300
Labeler code
50405
Product ID
50405-300_8d5b3de5-1dce-43e9-9858-c0439034f86a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET
Route
ORAL
Labeler
SOHM, Inc.
Application
ANDA079042
Marketing category
ANDA
Marketing start
2024-05-27
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, 387003

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
50405-300-01Levetiracetam30 in 1 BOTTLETABLET306
50405-300-02Levetiracetam120 in 1 BOTTLETABLET1206
50405-300-03Levetiracetam500 in 1 BOTTLETABLET5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50405-300LEVETIRACETAM TABLET [SOHM, INC.]5Current NDC, 3 package rows20241130_0a688786-879b-4e27-a46a-5c86bbfa1292.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN0a688786-879b-4e27-a46a-5c86bbfa12926
311288levETIRAcetam 250 MG Oral TabletPSN0a688786-879b-4e27-a46a-5c86bbfa12926
311289levETIRAcetam 500 MG Oral TabletPSN0a688786-879b-4e27-a46a-5c86bbfa12926
311290levETIRAcetam 750 MG Oral TabletPSN0a688786-879b-4e27-a46a-5c86bbfa12926
387003levetiracetam 1000 MG Oral TabletSCD0a688786-879b-4e27-a46a-5c86bbfa12926
311288levetiracetam 250 MG Oral TabletSCD0a688786-879b-4e27-a46a-5c86bbfa12926
311289levetiracetam 500 MG Oral TabletSCD0a688786-879b-4e27-a46a-5c86bbfa12926
311290levetiracetam 750 MG Oral TabletSCD0a688786-879b-4e27-a46a-5c86bbfa12926

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50405-300-015040503000130 TABLET in 1 BOTTLE (50405-300-01) 30 tablet2024-05-27NoNoCurrent
50405-300-0250405030002120 TABLET in 1 BOTTLE (50405-300-02) 120 tablet2024-05-27NoNoCurrent
50405-300-0350405030003500 TABLET in 1 BOTTLE (50405-300-03) 500 tablet2024-05-27NoNoCurrent