FDA.reportPublic FDA data

LEVETIRACETAM

Product NDC
72189-190
11-digit product format
721890190
Labeler code
72189
Product ID
72189-190_4c4bd407-ac66-f594-e063-6294a90a31fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090515
Marketing category
ANDA
Marketing start
2021-06-07
Substance
LEVETIRACETAM
Active strength
250 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
LEVETIRACETAM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui311288, 311289

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
72189-190-30LEVETIRACETAM30 in 1 BOTTLETABLET, FILM COATED308
72189-190-60LEVETIRACETAM60 in 1 BOTTLETABLET, FILM COATED608
72189-190-72LEVETIRACETAM120 in 1 BOTTLETABLET, FILM COATED1208
72189-190-90LEVETIRACETAM90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-190LEVETIRACETAM TABLET, FILM COATED [DIRECT RX]7Current NDC, Legacy NDC, 4 package rows20250425_c3b62114-a590-f4db-e053-2995a90a9d30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311288levETIRAcetam 250 MG Oral TabletPSNc3b62114-a590-f4db-e053-2995a90a9d308
311289levETIRAcetam 500 MG Oral TabletPSNc3b62114-a590-f4db-e053-2995a90a9d308
311288levetiracetam 250 MG Oral TabletSCDc3b62114-a590-f4db-e053-2995a90a9d308
311289levetiracetam 500 MG Oral TabletSCDc3b62114-a590-f4db-e053-2995a90a9d308

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-190-307218901903030 TABLET, FILM COATED in 1 BOTTLE (72189-190-30) 2021-06-070000-00-00NoNoCurrent
72189-190-607218901906060 TABLET, FILM COATED in 1 BOTTLE (72189-190-60) 2021-06-070000-00-00NoNoCurrent
72189-190-7272189019072120 TABLET, FILM COATED in 1 BOTTLE (72189-190-72) 2021-06-07NoNoCurrent
72189-190-907218901909090 TABLET, FILM COATED in 1 BOTTLE (72189-190-90) 2021-06-07NoNoCurrent