Levetiracetam (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — LABEL — 500MG

NDC 47335-573-86
Once Daily Dosing
Levetiracetam Extended-release Tablets
500 mg
PHARMACIST: Please dispense with medication guide provided separately to each patient.
Rx only
60 TABLETS SUN PHARMA

levetiracetam-500mg
(click image for full-size original)

levetiracetam-500mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — LABEL — 750MG

NDC 47335-576-86
Once Daily Dosing
Levetiracetam Extended-Release Tablets
750 mg
PHARMACIST: Please dispense with medication guide provided separately to each patient.
Rx only
60 TABLETS SUN PHARMA

levetiracetam-750mg
(click image for full-size original)
LEVETIRACETAM levetiracetam tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-573
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
POVIDONE K90
HYPROMELLOSE 2208 (15000 MPA.S)
DIMETHYLAMINOETHYL METHACRYLATE — BUTYL METHACRYLATE — METHYL METHACRYLATE COPOLYMER
SILICON DIOXIDE
MAGNESIUM STEARATE
TALC
CROSPOVIDONE (120 .MU.M)
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
ETHYLCELLULOSE, UNSPECIFIED
DIBUTYL SEBACATE
TRIETHYL CITRATE
POLYSORBATE 20
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL 3350
POLYSORBATE 80
Product Characteristics
Color BLUE, WHITE (white to off-white) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code 573
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-573-86 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:47335-573-88 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:47335-573-13 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203059 09/09/2013
LEVETIRACETAM levetiracetam tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-576
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
POVIDONE K90
HYPROMELLOSE 2208 (15000 MPA.S)
DIMETHYLAMINOETHYL METHACRYLATE — BUTYL METHACRYLATE — METHYL METHACRYLATE COPOLYMER
SILICON DIOXIDE
MAGNESIUM STEARATE
TALC
CROSPOVIDONE (120 .MU.M)
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
ETHYLCELLULOSE, UNSPECIFIED
DIBUTYL SEBACATE
TRIETHYL CITRATE
POLYSORBATE 20
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL 3350
POLYSORBATE 80
Product Characteristics
Color BLUE, WHITE (white to off-white) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code 576
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-576-86 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:47335-576-88 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:47335-576-13 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203059 09/09/2013
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 725959238 ANALYSIS (47335-573), ANALYSIS (47335-576), MANUFACTURE (47335-573), MANUFACTURE (47335-576)

Revised: 10/2020 Sun Pharmaceutical Industries, Inc.

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