Levetiracetam

Product NDC
60429-349
11-digit product format
604290349
Labeler code
60429
Product ID
60429-349_445d08d0-1f31-1ac0-e063-6394a90a2cdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA091261
Marketing category
ANDA
Marketing start
2011-09-12
Substance
LEVETIRACETAM
Active strength
500 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
Brand name suffix
Extended-Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui807832, 846378

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
60429-349-60LevetiracetamExtended-Release60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-349-60EA - Each60429-349a0381893-526a-48ea-930e-1f5ae332888412014-08-01

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-349LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]12Current NDC, Legacy NDC, 1 package rows20250406_5dde1889-a217-4493-9a71-9fd39ed04630.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
807832levETIRAcetam 500 MG 24HR Extended Release Oral TabletPSN5dde1889-a217-4493-9a71-9fd39ed0463013
846378levETIRAcetam 750 MG 24HR Extended Release Oral TabletPSN5dde1889-a217-4493-9a71-9fd39ed0463013
80783224 HR levetiracetam 500 MG Extended Release Oral TabletSCD5dde1889-a217-4493-9a71-9fd39ed0463013
84637824 HR levetiracetam 750 MG Extended Release Oral TabletSCD5dde1889-a217-4493-9a71-9fd39ed0463013
807832levetiracetam 500 MG 24 HR Extended Release Oral TabletSY5dde1889-a217-4493-9a71-9fd39ed0463013
846378levetiracetam 750 MG 24 HR Extended Release Oral TabletSY5dde1889-a217-4493-9a71-9fd39ed0463013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-349-606042903496060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60429-349-60) 2012-10-310000-00-00NoNoCurrent