Levetiracetam (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 250 mg Tablet Bottle Label

NDC 51672-4141-6

30 Tablets

Levetiracetam Tablets, USP

250 mg

Rx only

ATTENTION PHARMACIST:
Each patient is required
to receive the accompanying Medication Guide.

PRINCIPAL DISPLAY PANEL -- 250 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 500 mg Tablet Bottle Label

NDC 51672-4142-6

30 Tablets

ATTENTION PHARMACIST:
Each patient is required to receive the
accompanying Medication Guide.

Levetiracetam Tablets, USP

500 mg

TARO

Rx only

PRINCIPAL DISPLAY PANEL -- 500 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 750 mg Tablet Bottle Label

NDC 51672-4143-6

30 Tablets

ATTENTION PHARMACIST:
Each patient is required to receive the
accompanying Medication Guide.

Levetiracetam Tablets, USP

750 mg

TARO

Rx only

PRINCIPAL DISPLAY PANEL -- 750 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1000 mg Tablet Bottle Label

NDC 51672-4137-6

30 Tablets

ATTENTION PHARMACIST:
Each patient is required to receive the
accompanying Medication Guide.

Levetiracetam Tablets, USP

1000 mg

TARO

Rx only

PRINCIPAL DISPLAY PANEL -- 1000 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 473 mL Bottle Label

16 fl oz (473 mL)

NDC 51672-4136-9

Levetiracetam Oral Solution, USP

100 mg/mL

Rx only

ATTENTION PHARMACIST: Each
patient is required to receive the
accompanying Medication Guide.
Dispense in a tight,light-resistant
container with a child-resistant
closure.

Usual dosage: see package insert for full
prescribing information.
Store at 20 °-25 °C (68 °-77 °F) [see USP
Controlled Room Temperature].
Warning: Keep this and all medications out
of the reach of children.
Mfd. by: Taro Pharmaceutical Industries Ltd.
Haifa Bay, Israel 2624761
Dist. by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
TARO is a registered trademark of
Taro Pharmaceuticals U.S.A., Inc.70656-0115-3

TARO

PRINCIPAL DISPLAY PANEL -- 473 mL Bottle Label
(click image for full-size original)
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4141
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
silicon dioxide
starch, corn
magnesium stearate
povidone, unspecified
talc
FD&C Blue no. 2
indigotindisulfonate sodium
aluminum oxide
hypromellose, unspecified
polyethylene glycol, unspecified
titanium dioxide
Product Characteristics
Color BLUE Score 2 pieces
Shape OVAL (caplet shaped) Size 13mm
Flavor Imprint Code LVT;250;TARO
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-4141-6 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:51672-4141-1 120 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:51672-4141-3 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:51672-4141-0 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (51672-4141-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078960 02/01/2010
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4142
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
silicon dioxide
starch, corn
magnesium stearate
povidone, unspecified
talc
hypromellose, unspecified
ferrosoferric oxide
ferric oxide red
ferric oxide yellow
polyethylene glycol, unspecified
titanium dioxide
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL (Caplet shaped) Size 18mm
Flavor Imprint Code LVT;500;TARO
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-4142-6 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:51672-4142-1 120 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:51672-4142-3 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:51672-4142-0 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (51672-4142-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078960 02/01/2010
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4143
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
silicon dioxide
starch, corn
magnesium stearate
povidone, unspecified
talc
hypromellose, unspecified
ferrosoferric oxide
ferric oxide red
ferric oxide yellow
polyethylene glycol, unspecified
titanium dioxide
Product Characteristics
Color ORANGE (Peach) Score 2 pieces
Shape OVAL (caplet shaped) Size 20mm
Flavor Imprint Code LVT;750;TARO
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-4143-6 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:51672-4143-1 120 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:51672-4143-3 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:51672-4143-0 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (51672-4143-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078960 02/01/2010
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4137
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levetiracetam (Levetiracetam) Levetiracetam 1000 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
starch, corn
magnesium stearate
povidone, unspecified
talc
hypromellose, unspecified
polyethylene glycol, unspecified
titanium dioxide
Product Characteristics
Color WHITE (white to off white) Score 2 pieces
Shape OVAL (caplet shaped) Size 22mm
Flavor Imprint Code LVT;1000;TARO
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-4137-6 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:51672-4137-4 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:51672-4137-8 750 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078960 02/01/2010
LEVETIRACETAM levetiracetam solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4136
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levetiracetam (Levetiracetam) Levetiracetam 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
acesulfame potassium
citric acid monohydrate
glycerin
methylparaben
ammonium glycyrrhizate
propylparaben
water
trisodium citrate dihydrate
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-4136-7 100 mL in 1 BOTTLE None
2 NDC:51672-4136-9 473 mL in 1 BOTTLE None
3 NDC:51672-4136-0 3785 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078774 02/10/2009
Labeler — Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE (51672-4141), MANUFACTURE (51672-4142), MANUFACTURE (51672-4143), MANUFACTURE (51672-4137), MANUFACTURE (51672-4136)

Revised: 07/2020 Taro Pharmaceuticals U.S.A., Inc.

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