FDA.reportPublic FDA data

LEVETIRACETAM

Product NDC
70518-4005
11-digit product format
705184005
Labeler code
70518
Product ID
70518-4005_4c965546-7569-17cd-e063-6394a90aef59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203468
Marketing category
ANDA
Marketing start
2024-01-31
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
Rxcui807832

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
70518-4005-0LEVETIRACETAM30 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE306
70518-4005-1LEVETIRACETAM30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4005LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.]4Current NDC, 2 package rows20250327_9bdef24b-c50e-4e6a-8650-59d78009f472.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
807832levETIRAcetam 500 MG 24HR Extended Release Oral TabletPSN9bdef24b-c50e-4e6a-8650-59d78009f4726
80783224 HR levetiracetam 500 MG Extended Release Oral TabletSCD9bdef24b-c50e-4e6a-8650-59d78009f4726
807832levetiracetam 500 MG 24 HR Extended Release Oral TabletSY9bdef24b-c50e-4e6a-8650-59d78009f4726

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4005-07051840050030 in 1 BLISTER PACKHistorical
70518-4005-17051840050130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4005-1) 2025-03-25NoNoHistorical