NDC 80705-100

ELEPSIA XR 1000 MG

Levetiracetam

ELEPSIA XR 1000 MG is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Tripoint Therapeutics, Llc. The primary component is Levetiracetam.

Product ID80705-100_11662182-a84d-455b-a4ee-5a97cd532b48
NDC80705-100
Product TypeHuman Prescription Drug
Proprietary NameELEPSIA XR 1000 MG
Generic NameLevetiracetam
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2021-02-12
Marketing CategoryNDA /
Application NumberNDA204417
Labeler NameTRIPOINT THERAPEUTICS, LLC
Substance NameLEVETIRACETAM
Active Ingredient Strength1000 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 80705-100-02

1 BLISTER PACK in 1 CARTON (80705-100-02) > 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2021-09-29
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "ELEPSIA XR 1000 MG" or generic name "Levetiracetam"

NDCBrand NameGeneric Name
0054-0224LevetiracetamLevetiracetam
0121-0799LevetiracetamLEVETIRACETAM
0121-1598LevetiracetamLEVETIRACETAM
0121-2397LevetiracetamLEVETIRACETAM
0121-4799LevetiracetamLEVETIRACETAM
0121-4802LEVETIRACETAMLEVETIRACETAM
0143-9574LevetiracetamLevetiracetam
0143-9673LevetiracetamLevetiracetam
0228-2167LevetiracetamLevetiracetam
0378-5613Levetiracetamlevetiracetam
0378-5615Levetiracetamlevetiracetam
0378-5617Levetiracetamlevetiracetam

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.