FDA.reportPublic FDA data

Levetiracetam

Product NDC
50228-471
11-digit product format
502280471
Labeler code
50228
Product ID
50228-471_1ea253c3-3086-2b26-e063-6394a90a312e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA215069
Marketing category
ANDA
Marketing start
2022-05-27
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui311288, 311289, 311290, 387003

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
50228-471-05Levetiracetam500 in 1 BOTTLETABLET, FILM COATED5005
50228-471-10Levetiracetam1000 in 1 BOTTLETABLET, FILM COATED10005
50228-471-12Levetiracetam120 in 1 BOTTLETABLET, FILM COATED1205
50228-471-30Levetiracetam30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-471-05EA - Each50228-4713416125f-4212-4069-9824-9c19dbefd30412022-10-06
50228-471-12EA - Each50228-47162146db3-3306-4d6e-a75c-84c46d8a7e8c12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-471LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM (LEVETIRACETAM) TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 4 package rows20240802_1d71212b-ac97-4a61-8192-8e8303540019.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN1d71212b-ac97-4a61-8192-8e83035400195
311288levETIRAcetam 250 MG Oral TabletPSN1d71212b-ac97-4a61-8192-8e83035400195
311289levETIRAcetam 500 MG Oral TabletPSN1d71212b-ac97-4a61-8192-8e83035400195
311290levETIRAcetam 750 MG Oral TabletPSN1d71212b-ac97-4a61-8192-8e83035400195
387003levetiracetam 1000 MG Oral TabletSCD1d71212b-ac97-4a61-8192-8e83035400195
311288levetiracetam 250 MG Oral TabletSCD1d71212b-ac97-4a61-8192-8e83035400195
311289levetiracetam 500 MG Oral TabletSCD1d71212b-ac97-4a61-8192-8e83035400195
311290levetiracetam 750 MG Oral TabletSCD1d71212b-ac97-4a61-8192-8e83035400195

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50228-471-0550228047105500 TABLET, FILM COATED in 1 BOTTLE (50228-471-05) 2022-05-270000-00-00NoNoCurrent
50228-471-10502280471101000 TABLET, FILM COATED in 1 BOTTLE (50228-471-10) 2022-05-270000-00-00NoNoCurrent
50228-471-1250228047112120 TABLET, FILM COATED in 1 BOTTLE (50228-471-12) 2022-05-270000-00-00NoNoCurrent
50228-471-305022804713030 TABLET, FILM COATED in 1 BOTTLE (50228-471-30) 2022-05-270000-00-00NoNoCurrent