ZONISAMIDE- zonisamide capsule 
Cadila Healthcare Limited

----------

Zonisamide Capsules

Manufactured by:

Cadila Healthcare Ltd.

India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1142-1 in bottle of 100 Capsules

Zonisamide Capsules, 25 mg

Rx only

100 Capsules

Zonisamide Capsules, 25 mg

NDC 70771-1143-1 in bottle of 100 Capsules

Zonisamide Capsules, 50 mg

Rx only

100 Capsules

Zonisamide Capsules, 50 mg

NDC 70771-1144-1 in bottle of 100 Capsules

Zonisamide Capsules, 100 mg

Rx only

100 Capsules

Zonisamide Capsules, 100 mg
ZONISAMIDE 
zonisamide capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1142
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZONISAMIDE (UNII: 459384H98V) (ZONISAMIDE - UNII:459384H98V) ZONISAMIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
GELATIN (UNII: 2G86QN327L)  
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINK (PINK) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size14mm
FlavorImprint Code ZA;31
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1142-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/22/2017
2NDC:70771-1142-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/22/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07762511/22/2017
ZONISAMIDE 
zonisamide capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1143
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZONISAMIDE (UNII: 459384H98V) (ZONISAMIDE - UNII:459384H98V) ZONISAMIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
GELATIN (UNII: 2G86QN327L)  
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINK (PINK) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size16mm
FlavorImprint Code ZA;32
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1143-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/22/2017
2NDC:70771-1143-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/22/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07762511/22/2017
ZONISAMIDE 
zonisamide capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1144
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZONISAMIDE (UNII: 459384H98V) (ZONISAMIDE - UNII:459384H98V) ZONISAMIDE100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
GELATIN (UNII: 2G86QN327L)  
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINK (PINK) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code ZA;33
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1144-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/22/2017
2NDC:70771-1144-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/22/2017
3NDC:70771-1144-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/22/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07762511/22/2017
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(70771-1142, 70771-1143, 70771-1144) , MANUFACTURE(70771-1142, 70771-1143, 70771-1144)

Revised: 8/2020
Document Id: 73e03d89-e870-4ccb-92c9-08b077a44be8
Set id: 4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f
Version: 5
Effective Time: 20200807
 
Cadila Healthcare Limited