Levetiracetam (Page 10 of 10)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 250 mg (120 Tablets Bottle)

NDC 52343-069-12
Levetiracetam Tablets USP
250 mg
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY
Rx only 120 Tablets
Acetris Health, LLC

levetiracetam250mg120ct
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg (120 Tablets Bottle)

NDC 52343-070-12
Levetiracetam Tablets USP
500 mg
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY
Rx only 120 Tablets
Acetris Health, LLC

levetiracetam500mg120ct
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 750 mg (120 Tablets Bottle)

NDC 52343-071-12
Levetiracetam Tablets USP
750 mg
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY
Rx only 120 Tablets
Acetris Health, LLC

levetiracetam750mg120ct
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 1000 mg (60 Tablets Bottle)

NDC 52343-072-60
Levetiracetam Tablets USP
1000 mg
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY
Rx only 60 Tablets
Acetris Health, LLC

levetiracetam1000mg60ct
(click image for full-size original)

LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52343-069
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:52343-069-12 120 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:52343-069-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078993 11/06/2014
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52343-070
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:52343-070-12 120 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:52343-070-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078993 11/06/2014
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52343-071
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:52343-071-12 120 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:52343-071-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078993 11/06/2014
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52343-072
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 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:52343-072-60 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078993 11/06/2014
Labeler — ACETRIS HEALTH, LLC (080500964)
Establishment
Name Address ID/FEI Operations
Aurolife Pharma, LLC 829084461 MANUFACTURE (52343-069), MANUFACTURE (52343-070), MANUFACTURE (52343-071), MANUFACTURE (52343-072)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917662 ANALYSIS (52343-069), ANALYSIS (52343-070), ANALYSIS (52343-071), ANALYSIS (52343-072), API MANUFACTURE (52343-069), API MANUFACTURE (52343-070), API MANUFACTURE (52343-071), API MANUFACTURE (52343-072)

Revised: 09/2019 ACETRIS HEALTH, LLC

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