Levetiracetam (Page 10 of 10)

Package/Label Display Panel – Carton – 250 mg

250 mg Levetiracetam Tablets Carton
(click image for full-size original)

NDC 68084- 859 -01

Levetiracetam
Tablets USP

250 mg

100 Tablets (10 × 10)               Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Film-Coated Tablet Contains:
Levetiracetam USP ………………………………………………………..250 mg

Usual Dosage: See package insert for full prescribing information.

Store at 20º to 25ºC (68º to 77ºF); excursions permitted between
15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 65862-245, Aurobindo Pharma USA Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

085901 0285901/0918

Package/Label Display Panel – Blister – 250 mg

250 mg Levetiracetam Tablet Blister
(click image for full-size original)

Levetiracetam Tablet USP

250 mg

Package/Label Display Panel – Carton – 500 mg

500 mg Levetiracetam Tablets Carton
(click image for full-size original)

NDC 68084- 870 -01

Levetiracetam
Tablets USP

500 mg

100 Tablets (10 × 10)               Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Film-Coated Tablet Contains:
Levetiracetam USP……………………………………………..500 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20º to 25ºC (68º to 77ºF); excursions permitted
between 15º to 30ºC (59º to 86ºF) [see USP Controlled
Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 65862-246, Aurobindo Pharma Limited.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

087001 0287001/0918A

Package/Label Display Panel – Blister – 500 mg

500 mg Levetiracetam Blister
(click image for full-size original)

Levetiracetam Tablet USP

500 mg

Package/Label Display Panel – Carton – 750 mg

750 mg Levetiracetam Tablets Carton
(click image for full-size original)

NDC 68084- 882 -01

Levetiracetam
Tablets USP

750 mg

100 Tablets (10 × 10)               Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Film-Coated Tablet Contains:
Levetiracetam USP……………………………………………..750 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20º to 25ºC (68º to 77ºF); excursions permitted
between 15º to 30ºC (59º to 86ºF) [see USP Controlled
Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 65862-247, Aurobindo Pharma USA, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

088201 0288201/0918

Package/Label Display Panel – Blister – 750 mg

750 mg Levetiracetam Tablet Blister
(click image for full-size original)

Levetiracetam Tablet USP

750 mg

Package/Label Display Panel – Carton – 1000 mg

1000 mg Levetiracetam Tablets Carton
(click image for full-size original)

NDC 68084- 893 -01

Levetiracetam
Tablets USP

1000 mg

100 Tablets (10 × 10)               Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Film-Coated Tablet Contains:
Levetiracetam USP……………………………………………1000 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20º to 25ºC (68º to 77ºF); excursions permitted
between 15º to 30ºC (59º to 86ºF) [see USP Controlled
Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 65862-315, Aurobindo Pharma Limited.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

089301 0289301/0918

Package/Label Display Panel – Blister – 1000 mg

1000 mg Levetiracetam Tablet Blister
(click image for full-size original)

Levetiracetam Tablet USP

1000 mg

LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-859(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:68084-859-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-859-11)
1 NDC:68084-859-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-859-01)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078993 11/21/2014
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-870(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:68084-870-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-870-11)
1 NDC:68084-870-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-870-01)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078993 12/03/2014
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-882(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:68084-882-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-882-11)
1 NDC:68084-882-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-882-01)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078993 02/27/2015
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-893(NDC:65862-315)
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
STARCH, CORN
SILICON DIOXIDE
POVIDONE K30
TALC
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (5 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
WATER
Product Characteristics
Color white (White to Off-white) Score 2 pieces
Shape OVAL (Modified Oval, Biconvex) Size 22mm
Flavor Imprint Code E;13
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-893-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-893-11)
1 NDC:68084-893-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-893-01)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078993 03/03/2015
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (68084-859), repack (68084-870), repack (68084-882), repack (68084-893)

Revised: 07/2021 American Health Packaging

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