Levetiracetam (Page 10 of 10)

Package/Label Display Panel

Levetiracetam Tablets, USP

250 mg

100 Tablets

carton label
(click image for full-size original)

Package/Label Display Panel

Levetiracetam Tablets USP

500 mg

100 Tablets

carton label
(click image for full-size original)

Package/Label Display Panel

Levetiracetam Tablets USP

750 mg

100 Tablets

carton label
(click image for full-size original)
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-7123(NDC:65862-245)
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
STARCH, CORN
SILICON DIOXIDE
POVIDONE K30
TALC
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 4000
WATER
FD&C BLUE NO. 2
Product Characteristics
Color BLUE Score 2 pieces
Shape OVAL (Biconvex) Size 15mm
Flavor Imprint Code E;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-7123-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-7123-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078993 01/15/2009
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-7124(NDC:65862-246)
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
STARCH, CORN
SILICON DIOXIDE
POVIDONE K30
TALC
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 4000
WATER
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL (Biconvex) Size 18mm
Flavor Imprint Code E;11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-7124-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-7124-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078993 01/15/2009
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-7125(NDC:65862-247)
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
STARCH, CORN
SILICON DIOXIDE
POVIDONE K30
TALC
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 4000
WATER
FD&C YELLOW NO. 6
FD&C BLUE NO. 2
FERRIC OXIDE RED
Product Characteristics
Color ORANGE Score 2 pieces
Shape OVAL (Biconvex) Size 20mm
Flavor Imprint Code E;12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-7125-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-7125-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078993 01/15/2009
Labeler — Major Pharmaceuticals (191427277)

Revised: 05/2021 Major Pharmaceuticals

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