Levetiracetam

Product NDC
42385-955
11-digit product format
423850955
Labeler code
42385
Product ID
42385-955_cbdae2e4-1013-e3d8-e053-2995a90a625c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET
Route
ORAL
Labeler
Laurus Generics Inc.
Application
ANDA090767
Marketing category
ANDA
Marketing start
2021-03-22
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
500 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42385-955-05EA - Each42385-9553759359e-2c48-4674-b99b-af2dd908a7bd12021-05-05
42385-955-12EA - Each42385-955f312d25d-06b5-469d-af5b-1104ed75abfd12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42385-955LEVETIRACETAM TABLET [LAURUS GENERICS INC.]3Legacy NDC20250121_6c7d64d6-1105-4eb6-abaf-bc41fdfe00bd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42385-955-0542385095505500 TABLET in 1 BOTTLE (42385-955-05) 500 tablet2021-03-220000-00-00NoNoCurrent
42385-955-1242385095512120 TABLET in 1 BOTTLE (42385-955-12) 120 tablet2021-03-220000-00-00NoNoCurrent