FDA.reportPublic FDA data

Levetiracetam

Product NDC
50228-189
11-digit product format
502280189
Labeler code
50228
Product ID
50228-189_1d0dd4a0-35e6-418b-e063-6394a90a8b2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levetiracetam
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc
Application
ANDA205130
Marketing category
ANDA
Marketing start
2020-11-27
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
50228-189-05LevetiracetamExtended-Release500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5004
50228-189-30LevetiracetamExtended-Release30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE304
50228-189-60LevetiracetamExtended-Release60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-189-60EA - Each50228-1894a4cbfce-c71b-402c-a3bb-0757499cceb712021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-189LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [SCIEGEN PHARMACEUTICALS, INC]4Current NDC, Legacy NDC, 3 package rows20240713_3e32f341-9926-47a3-a942-d8b9bfa7a55b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
807832levETIRAcetam 500 MG 24HR Extended Release Oral TabletPSN3e32f341-9926-47a3-a942-d8b9bfa7a55b4
846378levETIRAcetam 750 MG 24HR Extended Release Oral TabletPSN3e32f341-9926-47a3-a942-d8b9bfa7a55b4
80783224 HR levetiracetam 500 MG Extended Release Oral TabletSCD3e32f341-9926-47a3-a942-d8b9bfa7a55b4
84637824 HR levetiracetam 750 MG Extended Release Oral TabletSCD3e32f341-9926-47a3-a942-d8b9bfa7a55b4
807832levetiracetam 500 MG 24 HR Extended Release Oral TabletSY3e32f341-9926-47a3-a942-d8b9bfa7a55b4
846378levetiracetam 750 MG 24 HR Extended Release Oral TabletSY3e32f341-9926-47a3-a942-d8b9bfa7a55b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50228-189-0550228018905500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-189-05) 2020-11-270000-00-00NoNoCurrent
50228-189-305022801893030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-189-30) 2020-11-270000-00-00NoNoCurrent
50228-189-605022801896060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-189-60) 2020-11-270000-00-00NoNoCurrent