levetiracetam

Product NDC
59746-591
11-digit product format
597460591
Labeler code
59746
Product ID
59746-591_9bcb1710-fc95-49ff-b724-72f5f68ac9b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam Injection
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Jubilant Cadista Pharmaceuticals Inc.
Application
ANDA206838
Marketing category
ANDA
Marketing start
2016-06-02
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
100 mg/mL
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-591LEVETIRACETAM (LEVETIRACETAM INJECTION) INJECTION, SOLUTION, CONCENTRATE [JUBILANT CADISTA PHARMACEUTICALS INC.]6Legacy NDC20210115_0d7d109f-15fc-4d95-ef6a-0e82aa98b30c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-591-105974605911010 VIAL in 1 CARTON (59746-591-10) > 5 mL in 1 VIAL (59746-591-01) 10 vial2016-06-020000-00-00NoNoCurrent
59746-591-235974605912325 VIAL in 1 CARTON (59746-591-23) > 5 mL in 1 VIAL (59746-591-01) 25 vial2016-06-020000-00-00NoNoCurrent