Levetiracetam (Page 10 of 10)

What are the ingredients of levetiracetam tablets?

Levetiracetam tablets

active ingredient: levetiracetam

For 250 mg, 500 mg and 750 mg strengths:

Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below:

250 mg tablets: FD&C Blue #2 aluminum lake

500 mg tablets: Yellow Iron Oxide

750 mg tablets: FD&C Blue #2 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide red

For 1000 mg strength:

Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

Levetiracetam tablets do not contain lactose or gluten.

Information on the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

This Medication Guide has been approved by the US Food and Drug Administration.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States.

MADE IN INDIA.

Repackaged By :
Aidarex Pharmaceuticals LLC,Corona, CA 92880

November 2013 ID#: 233261

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Levetiracetam Tablets USP

Rx Only

250 mg

NDC 33261-0644-30

30’s Bottle

IMAGE LABEL
(click image for full-size original)

Levetiracetam Tablets USP

Rx Only

500 mg

NDC 33261-0645-30

30’s Bottle

IMAGE LABEL
(click image for full-size original)

Levetiracetam Tablets USP

Rx Only

750 mg

NDC 33261-0646-60

60’s Bottle Pack

IMAGE LABEL
(click image for full-size original)
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-644(NDC:68180-112)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 250 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
CROSPOVIDONE
FD&C BLUE NO. 2
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 4000
POLYVINYL ALCOHOL
POVIDONES
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (Blue) Score 2 pieces
Shape OVAL (Oblong-shaped, Biconvex, Film-Coated) Size 15mm
Flavor Imprint Code L;U;X01
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33261-644-30 30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:33261-644-60 60 TABLET, FILM COATED (60 TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078154 01/01/2009
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-645(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
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
CROSPOVIDONE
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 4000
POLYVINYL ALCOHOL
POVIDONES
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:33261-645-30 30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:33261-645-60 60 TABLET, FILM COATED (60 TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078154 01/01/2009
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-646(NDC:68180-114)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 750 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
CROSPOVIDONE
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
FERRIC OXIDE RED
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 4000
POLYVINYL ALCOHOL
POVIDONES
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE (Orange) Score 2 pieces
Shape OVAL (Oblong-shaped, Biconvex, Film-Coated) Size 20mm
Flavor Imprint Code L;U;X03
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33261-646-60 60 TABLET, FILM COATED (60 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:33261-646-90 90 TABLET, FILM COATED (90 TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078154 01/01/2009
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 01/2014 Aidarex Pharmaceuticals LLC

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