Elepsia XR (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-1000 mg

NDC 47133-574-88
Elepsia™ XR (levetiracetam)
Extended-release Tablets
1,000 mg
Once Daily Dosing
Swallow tablets whole,
do NOT chew, break, split, or crush tablets.
Rx only
100 Tablets
PHARMACIST: Please dispense with Medication
Guide provided separately to each patient.

image description
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-1500 mg

NDC 47133-575-13
Elepsia™ XR (levetiracetam)
Extended-release Tablets
1,500 mg
Once Daily Dosing
Swallow tablets whole,
do NOT chew, break, split, or crush tablets.
Rx only
500 Tablets
PHARMACIST: Please dispense with Medication
Guide provided separately to each patient.

image description
(click image for full-size original)

ELEPSIA XR levetiracetam tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47133-574
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
POVIDONE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
DIMETHYLAMINOETHYL METHACRYLATE — BUTYL METHACRYLATE — METHYL METHACRYLATE COPOLYMER
SILICON DIOXIDE
MAGNESIUM STEARATE
TALC
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
ETHYLCELLULOSE, UNSPECIFIED
DIBUTYL SEBACATE
TRIETHYL CITRATE
POLYSORBATE 20
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
SHELLAC
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
Product Characteristics
Color WHITE (White to off white layer) , BLUE (Blue layer) Score no score
Shape OVAL (biconvex) Size 19mm
Flavor Imprint Code 574
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47133-574-83 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:47133-574-88 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:47133-574-13 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204417 05/17/2019
ELEPSIA XR levetiracetam tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47133-575
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 1500 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
DIMETHYLAMINOETHYL METHACRYLATE — BUTYL METHACRYLATE — METHYL METHACRYLATE COPOLYMER
SILICON DIOXIDE
MAGNESIUM STEARATE
TALC
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
ETHYLCELLULOSE, UNSPECIFIED
DIBUTYL SEBACATE
TRIETHYL CITRATE
POLYSORBATE 20
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
SHELLAC
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
Product Characteristics
Color WHITE (White to off white layer) , BLUE (Blue layer) Score no score
Shape OVAL (biconvex) Size 24mm
Flavor Imprint Code 575
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47133-575-83 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:47133-575-88 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:47133-575-13 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204417 05/17/2019
Labeler — Sun Pharma Advanced Research Company Limited (676162401)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 725959238 analysis (47133-574), analysis (47133-575), manufacture (47133-574), manufacture (47133-575)

Revised: 01/2021 Sun Pharma Advanced Research Company Limited

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