Levetiracetam

Product NDC
68788-8254
11-digit product format
687888254
Labeler code
68788
Product ID
68788-8254_dbbfc67e-e438-40f9-bbee-56f0d0e25a29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA078154
Marketing category
ANDA
Marketing start
2022-09-02
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
44YRR34555LEVETIRACETAM102767-28-2LEVETIRACETAM

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8254-168788825401100 TABLET, FILM COATED in 1 BOTTLE (68788-8254-1) 2022-09-02NoNoHistorical
68788-8254-26878882540220 TABLET, FILM COATED in 1 BOTTLE (68788-8254-2) 2022-09-02NoNoHistorical
68788-8254-36878882540330 TABLET, FILM COATED in 1 BOTTLE (68788-8254-3) 2022-09-02NoNoHistorical
68788-8254-66878882540660 TABLET, FILM COATED in 1 BOTTLE (68788-8254-6) 2022-09-02NoNoHistorical
68788-8254-96878882540990 TABLET, FILM COATED in 1 BOTTLE (68788-8254-9) 2022-09-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LevetiracetamPreferred Pharmaceuticals, Inc.2025-07-11HUMAN PRESCRIPTION DRUG LABEL4