FDA.reportPublic FDA data

Levetiracetam

Product NDC
87063-192
11-digit product format
870630192
Labeler code
87063
Product ID
87063-192_5136a714-d33e-d2c8-e063-6294a90a0982
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET
Route
ORAL
Labeler
ASCLEMED USA INC.
Application
ANDA091491
Marketing category
ANDA
Marketing start
2023-05-01
Substance
LEVETIRACETAM
Active strength
750 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
LEVETIRACETAM750 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
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
87063-192-12Levetiracetam120 in 1 BOTTLETABLET1201
87063-192-30Levetiracetam30 in 1 BOTTLETABLET301
87063-192-60Levetiracetam60 in 1 BOTTLETABLET601
87063-192-90Levetiracetam90 in 1 BOTTLETABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSNa3c57d82-511c-4c7d-84ff-f791f931f5761
311288levETIRAcetam 250 MG Oral TabletPSNa3c57d82-511c-4c7d-84ff-f791f931f5761
311289levETIRAcetam 500 MG Oral TabletPSNa3c57d82-511c-4c7d-84ff-f791f931f5761
311290levETIRAcetam 750 MG Oral TabletPSNa3c57d82-511c-4c7d-84ff-f791f931f5761
387003levetiracetam 1000 MG Oral TabletSCDa3c57d82-511c-4c7d-84ff-f791f931f5761
311288levetiracetam 250 MG Oral TabletSCDa3c57d82-511c-4c7d-84ff-f791f931f5761
311289levetiracetam 500 MG Oral TabletSCDa3c57d82-511c-4c7d-84ff-f791f931f5761
311290levetiracetam 750 MG Oral TabletSCDa3c57d82-511c-4c7d-84ff-f791f931f5761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87063-192-1287063019212120 TABLET in 1 BOTTLE (87063-192-12) 120 tablet2026-05-07NoNoHistorical
87063-192-308706301923030 TABLET in 1 BOTTLE (87063-192-30) 30 tablet2026-05-07NoNoHistorical
87063-192-608706301926060 TABLET in 1 BOTTLE (87063-192-60) 60 tablet2026-05-07NoNoHistorical
87063-192-908706301929090 TABLET in 1 BOTTLE (87063-192-90) 90 tablet2026-05-07NoNoHistorical