Levetiracetam

LEVETIRACETAM- levetiracetam tablet, film coated
Cadila Healthcare Limited

Manufactured by:

Cadila Healthcare Ltd.

India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-703-19 in bottle of 120 tablets

Levetiracetam Tablets, 250 mg

Rx only

IMAGE
(click image for full-size original)

NDC 65841-704-10

Levetiracetam Tablets, 1000 mg

1000 tablets

Rx only

image
(click image for full-size original)
LEVETIRACETAM
levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-703
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
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces
Shape OVAL (OVAL) Size 13mm
Flavor Imprint Code ZE;32
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-703-19 120 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-703-10 1000 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-703-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-703-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078918 12/05/2017
LEVETIRACETAM
levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-704
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
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces
Shape OVAL (OVAL) Size 21mm
Flavor Imprint Code ZE;35
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-704-14 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-704-10 1000 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-704-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-704-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078918 12/05/2017
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-703), ANALYSIS (65841-704), MANUFACTURE (65841-703), MANUFACTURE (65841-704)

Revised: 08/2020 Cadila Healthcare Limited

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