LEVETIRACETAM (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Levetiracetam Tablet USP 250 mg

NDC 27241-007-12

120 tablets

Levetiracetam Tablets USP
250 mg tablets

PHARMACIST: Please dispense with attached Medication Guide.

Rx only

levetiracetam_250mg
(click image for full-size original)

Levetiracetam Tablet USP 500 mg

NDC 27241-008-12

120 tablets

Levetiracetam Tablets USP 500 mg tablets

PHARMACIST: Please dispense with attached Medication Guide.

Rx only

levetiracetam_500mg
(click image for full-size original)

Levetiracetam Tablet USP 750 mg

NDC 27241-009-12

120 tablets

Levetiracetam Tablets USP 750 mg tablets

PHARMACIST: Please dispense with attached Medication Guide.

Rx only

levetiracetam_750mg
(click image for full-size original)

Levetiracetam Tablet USP 1000 mg

NDC 27241-010-06

60 tablets

Levetiracetam Tablets USP
1000 mg tablets

PHARMACIST: Please dispense with attached Medication Guide.

Rx only

levetiracetam_1000
(click image for full-size original)

LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-007
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
Povidone K30
Silicon Dioxide
Talc
Magnesium Stearate
Polyvinyl Alcohol
Ferric Oxide Yellow
Polyethylene Glycol 3350
Titanium Dioxide
Lecithin, Soybean
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL (capsule) Size 13mm
Flavor Imprint Code L;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27241-007-12 120 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:27241-007-50 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:27241-007-90 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201293 06/14/2011
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-008
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
Povidone K30
Silicon Dioxide
Talc
Magnesium Stearate
Polyvinyl Alcohol
Ferric Oxide Red
FD&C Yellow No. 6
Polyethylene Glycol 3350
Titanium Dioxide
Lecithin, Soybean
Product Characteristics
Color ORANGE Score 2 pieces
Shape OVAL (capsule) Size 17mm
Flavor Imprint Code L;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27241-008-12 120 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:27241-008-50 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:27241-008-90 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201293 06/14/2011
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-009
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
Povidone K30
Silicon Dioxide
Talc
Magnesium Stearate
Polyvinyl Alcohol
FD&C Blue No. 2
Polyethylene Glycol 3350
Titanium Dioxide
Lecithin, Soybean
Product Characteristics
Color BLUE Score 2 pieces
Shape OVAL Size 20mm
Flavor Imprint Code L;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27241-009-12 120 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:27241-009-50 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:27241-009-90 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201293 06/14/2011
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-010
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
Povidone K30
Silicon Dioxide
Talc
Magnesium Stearate
Polyvinyl Alcohol
Polyethylene Glycol 3350
Titanium Dioxide
Lecithin, Soybean
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (capsule) Size 22mm
Flavor Imprint Code L;4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27241-010-06 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:27241-010-10 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:27241-010-90 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201293 06/14/2011
Labeler — Ajanta Pharma Limited (918594859)
Establishment
Name Address ID/FEI Operations
Ajanta Pharma Limited 918594859 MANUFACTURE (27241-007), MANUFACTURE (27241-008), MANUFACTURE (27241-009), MANUFACTURE (27241-010)

Revised: 11/2017 Ajanta Pharma Limited

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