FDA.reportPublic FDA data

Levetiracetam

Product NDC
64980-604
11-digit product format
649800604
Labeler code
64980
Product ID
64980-604_22c1d3b2-17b6-46b6-9474-ebe6cda4b2c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA090767
Marketing category
ANDA
Marketing start
2024-06-10
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
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
64980-604-01Levetiracetam100 in 1 BOTTLETABLET, FILM COATED1007
64980-604-12Levetiracetam120 in 1 BOTTLETABLET, FILM COATED1207
64980-604-50Levetiracetam500 in 1 BOTTLETABLET, FILM COATED5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-604-12EA - Each64980-6048f527a57-d992-4801-8e5f-12dbd29a935d12024-07-12
64980-604-50EA - Each64980-6042de52194-85b6-41ff-846a-4b8b7bbc769712024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-604LEVETIRACETAM TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]6Current NDC, 3 package rows20250529_db423b93-d7c2-4cf2-829b-24b657f27f93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSNdb423b93-d7c2-4cf2-829b-24b657f27f937
311288levETIRAcetam 250 MG Oral TabletPSNdb423b93-d7c2-4cf2-829b-24b657f27f937
311289levETIRAcetam 500 MG Oral TabletPSNdb423b93-d7c2-4cf2-829b-24b657f27f937
311290levETIRAcetam 750 MG Oral TabletPSNdb423b93-d7c2-4cf2-829b-24b657f27f937
387003levetiracetam 1000 MG Oral TabletSCDdb423b93-d7c2-4cf2-829b-24b657f27f937
311288levetiracetam 250 MG Oral TabletSCDdb423b93-d7c2-4cf2-829b-24b657f27f937
311289levetiracetam 500 MG Oral TabletSCDdb423b93-d7c2-4cf2-829b-24b657f27f937
311290levetiracetam 750 MG Oral TabletSCDdb423b93-d7c2-4cf2-829b-24b657f27f937

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
64980-604-0164980060401100 TABLET, FILM COATED in 1 BOTTLE (64980-604-01) 2024-06-10NoNoCurrent
64980-604-1264980060412120 TABLET, FILM COATED in 1 BOTTLE (64980-604-12) 2024-06-10NoNoCurrent
64980-604-5064980060450500 TABLET, FILM COATED in 1 BOTTLE (64980-604-50) 2024-06-10NoNoCurrent