FDA.reportPublic FDA data

Levetiracetam

Product NDC
71335-9757
11-digit product format
713359757
Labeler code
71335
Product ID
71335-9757_78a08eac-4bd1-4c6e-ba0a-4a71f5d4b7af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091491
Marketing category
ANDA
Marketing start
2023-05-01
Substance
LEVETIRACETAM
Active strength
500 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
LEVETIRACETAM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui311289

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
71335-9757-1Levetiracetam90 in 1 BOTTLETABLET90102
71335-9757-2Levetiracetam60 in 1 BOTTLETABLET60102
71335-9757-3Levetiracetam30 in 1 BOTTLETABLET30102
71335-9757-4Levetiracetam120 in 1 BOTTLETABLET120102
71335-9757-5Levetiracetam28 in 1 BOTTLETABLET28102
71335-9757-6Levetiracetam100 in 1 BOTTLETABLET100102
71335-9757-7Levetiracetam21 in 1 BOTTLETABLET21102
71335-9757-8Levetiracetam180 in 1 BOTTLETABLET180102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9757-1EA - Each71335-975701ff488c-fa62-4713-9763-0b3b8f98b4a312026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9757LEVETIRACETAM TABLET [BRYANT RANCH PREPACK]101Current NDC, 8 package rows20240601_7696961e-dfff-422a-b72f-e31ceeac10af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSN7696961e-dfff-422a-b72f-e31ceeac10af102
311289levetiracetam 500 MG Oral TabletSCD7696961e-dfff-422a-b72f-e31ceeac10af102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9757-17133597570190 TABLET in 1 BOTTLE (71335-9757-1) 90 tablet2023-09-27NoNoHistorical
71335-9757-27133597570260 TABLET in 1 BOTTLE (71335-9757-2) 60 tablet2024-05-22NoNoHistorical
71335-9757-37133597570330 TABLET in 1 BOTTLE (71335-9757-3) 30 tablet2026-04-08NoNoHistorical
71335-9757-471335975704120 TABLET in 1 BOTTLE (71335-9757-4) 120 tablet2023-12-08NoNoHistorical
71335-9757-57133597570528 TABLET in 1 BOTTLE (71335-9757-5) 28 tablet2026-04-08NoNoHistorical
71335-9757-671335975706100 TABLET in 1 BOTTLE (71335-9757-6) 100 tablet2026-04-08NoNoHistorical
71335-9757-77133597570721 TABLET in 1 BOTTLE (71335-9757-7) 21 tablet2026-04-08NoNoHistorical
71335-9757-871335975708180 TABLET in 1 BOTTLE (71335-9757-8) 180 tablet2026-04-08NoNoHistorical