FDA.reportPublic FDA data

Levetiracetam

Product NDC
70518-3895
11-digit product format
705183895
Labeler code
70518
Product ID
70518-3895_43e48e02-84e0-4b2e-e063-6294a90a7e83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091491
Marketing category
ANDA
Marketing start
2023-10-16
Substance
LEVETIRACETAM
Active strength
1000 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
LEVETIRACETAM1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui387003

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
70518-3895-0Levetiracetam30 in 1 BLISTER PACKTABLET306
70518-3895-1Levetiracetam60 in 1 BOTTLE, PLASTICTABLET606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3895LEVETIRACETAM TABLET [REMEDYREPACK INC.]4Current NDC, 2 package rows20250523_23073db5-3fc4-4051-a22d-e49a63e42647.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN23073db5-3fc4-4051-a22d-e49a63e426476
387003levetiracetam 1000 MG Oral TabletSCD23073db5-3fc4-4051-a22d-e49a63e426476

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3895-07051838950030 TABLET in 1 BLISTER PACK (70518-3895-0) 30 tablet2023-10-16NoNoHistorical
70518-3895-17051838950160 TABLET in 1 BOTTLE, PLASTIC (70518-3895-1) 60 tablet2024-10-02NoNoHistorical