MODAFINIL- modafinil tablet 
Zydus Lifesciences Limited

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MODAFINIL TABLETS CIV

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1051-3

Modafinil Tablets USP, 100 mg

30 Tablets

Rx only

Modafinil Tablets USP, 100mg and 200mg

NDC 70771-1052-3

Modafinil Tablets USP, 200 mg

30 Tablets

Rx only

Modafinil Tablets USP, 100mg and 200mg
MODAFINIL 
modafinil tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1051
Route of AdministrationORALDEA ScheduleCIV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MODAFINIL (UNII: R3UK8X3U3D) (MODAFINIL - UNII:R3UK8X3U3D) MODAFINIL100 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (OFF-WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size13mm
FlavorImprint Code 1072
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1051-330 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
2NDC:70771-1051-990 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
3NDC:70771-1051-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20996601/04/2018
MODAFINIL 
modafinil tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1052
Route of AdministrationORALDEA ScheduleCIV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MODAFINIL (UNII: R3UK8X3U3D) (MODAFINIL - UNII:R3UK8X3U3D) MODAFINIL200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (OFF-WHITE) Score2 pieces
ShapeCAPSULE (CAPSULE) Size16mm
FlavorImprint Code 10;73
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1052-330 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
2NDC:70771-1052-990 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
3NDC:70771-1052-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20996601/04/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1051, 70771-1052) , MANUFACTURE(70771-1051, 70771-1052)

Revised: 10/2023
Document Id: 3490f52c-d1ed-4c6a-9da3-27d06d7e8a0d
Set id: f39820fb-8248-4d42-854c-6fe2d9b92d36
Version: 5
Effective Time: 20231004
 
Zydus Lifesciences Limited