LEVETIRACETAM- levetiracetam tablet, film coated 
Zydus Lifesciences Limited

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LEVETIRACETAM TABLETS

Manufactured by:

Cadila Healthcare Ltd.

India

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-703-19 in bottle of 120 tablets

Levetiracetam Tablets, 250 mg

Rx only

IMAGE

NDC 65841-704-10

Levetiracetam Tablets, 1000 mg

1000 tablets

Rx only

image
LEVETIRACETAM 
levetiracetam tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-703
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555) LEVETIRACETAM250 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
POVIDONE (UNII: FZ989GH94E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeOVAL (OVAL) Size13mm
FlavorImprint Code ZE;32
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-703-19120 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
2NDC:65841-703-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
3NDC:65841-703-7710 in 1 CARTON12/05/2017
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07891812/05/2017
LEVETIRACETAM 
levetiracetam tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-704
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555) LEVETIRACETAM1000 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
POVIDONE (UNII: FZ989GH94E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeOVAL (OVAL) Size21mm
FlavorImprint Code ZE;35
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-704-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
2NDC:65841-704-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
3NDC:65841-704-7710 in 1 CARTON12/05/2017
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07891812/05/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-703, 65841-704) , MANUFACTURE(65841-703, 65841-704)

Revised: 9/2023
Document Id: 8f5c6dfd-ef46-4370-8ef7-50b1cef88dfc
Set id: d696e0d3-3d3d-4669-9fd7-4c96db490e57
Version: 6
Effective Time: 20230927
 
Zydus Lifesciences Limited