NAPROXEN- naproxen tablet 
Zydus Lifesciences Limited

----------

NAPROXEN TABLETS

Manufactured by:

Cadila Healthcare Ltd.

India

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-676-01

Naproxen tablets, 250 mg

100 Tablets

Rx only

Naproxen tablets

NDC 65841-677-01

Naproxen tablets, 375 mg

100 Tablets

Rx only

Naproxen tablets

NDC 65841-678-01

Naproxen tablets, 500 mg

100 Tablets

Rx only

Naproxen tablets
NAPROXEN 
naproxen tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-676
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN250 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorYELLOWScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code ZE10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-676-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
2NDC:65841-676-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07862011/09/2017
NAPROXEN 
naproxen tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-677
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN375 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorYELLOW (yellow) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code ZE9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-677-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
2NDC:65841-677-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
3NDC:65841-677-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07862011/09/2017
NAPROXEN 
naproxen tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-678
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorYELLOWScore2 pieces
ShapeCAPSULESize16mm
FlavorImprint Code ZE8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-678-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
2NDC:65841-678-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
3NDC:65841-678-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07862011/09/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-676, 65841-677, 65841-678) , MANUFACTURE(65841-676, 65841-677, 65841-678)

Revised: 9/2023
Document Id: aa74b720-15e7-489d-a00e-7ac6f49bb745
Set id: 94e84499-d536-457c-96e6-7569e8a179c4
Version: 5
Effective Time: 20230927
 
Zydus Lifesciences Limited