Levetiracetam (Page 9 of 9)

Levetiracetam

Label ImageLabel Image
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-2456(NDC:68180-113)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 500 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE, UNSPECIFIED
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 4000
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (Yellow) Score 2 pieces
Shape OVAL (Oblong-shaped, Biconvex, Film-Coated) Size 18mm
Flavor Imprint Code L;U;X02
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-2456-0 120 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:50090-2456-2 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078154 01/15/2009
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-2456)

Revised: 06/2021 A-S Medication Solutions

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