CLOBAZAM- clobazam tablet 
Zydus Lifesciences Limited

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CLOBAZAM TABLETS

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1440-1

Clobazam Tablets, 10 mg

100 Tablets

Rx only

Zydus

Clobazam tablets-

NDC 70771-1441-1

Clobazam Tablets, 20 mg

100 Tablets

Rx only

Zydus

Clobazam Tablets
CLOBAZAM 
clobazam tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1440
Route of AdministrationORALDEA ScheduleCIV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOBAZAM (UNII: 2MRO291B4U) (CLOBAZAM - UNII:2MRO291B4U) CLOBAZAM10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITE (OFF-WHITE) Score2 pieces
ShapeCAPSULE (MODIFIED CAPSULE) Size9mm
FlavorImprint Code 13;25
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1440-1100 in 1 BOTTLE; Type 0: Not a Combination Product10/22/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21144910/22/2018
CLOBAZAM 
clobazam tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1441
Route of AdministrationORALDEA ScheduleCIV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOBAZAM (UNII: 2MRO291B4U) (CLOBAZAM - UNII:2MRO291B4U) CLOBAZAM20 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITE (OFF-WHITE) Score2 pieces
ShapeCAPSULE (MODIFIED CAPSULE) Size11mm
FlavorImprint Code 13;26
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1441-1100 in 1 BOTTLE; Type 0: Not a Combination Product10/22/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21144910/22/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (863362789)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1440, 70771-1441) , MANUFACTURE(70771-1440, 70771-1441)

Revised: 11/2024
Document Id: 245aac68-1c33-4ee6-a892-d132e75264c5
Set id: c5082be6-fd29-4d56-a76c-ea2ba8ad8b93
Version: 6
Effective Time: 20241126
 
Zydus Lifesciences Limited