LEVETIRACETAM EXTENDED RELEASE

Product NDC
75834-246
11-digit product format
758340246
Labeler code
75834
Product ID
75834-246_69069c2b-6ee3-4003-b547-24d9a7a1b74c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA201464
Marketing category
ANDA
Marketing start
2020-09-16
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
750 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
75834-246-0575834024605500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (75834-246-05) 2020-09-160000-00-00NoNoCurrent
75834-246-607583402466060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (75834-246-60) 2020-09-160000-00-00NoNoCurrent