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 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 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 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 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