HYDROXYCHLOROQUINE SULFATE- hydroxychloroquine sulfate tablet, film coated 
Cadila Healthcare Limited

----------

Hydroxychloroquine sulfate tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-633-01 in bottle of 100 tablets

Hydroxychloroquine Sulfate Tablets USP, 200 mg

Rx only

100 tablets

Hydroxychloroquine sulfate tablets
HYDROXYCHLOROQUINE SULFATE 
hydroxychloroquine sulfate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-633
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROXYCHLOROQUINE SULFATE (UNII: 8Q2869CNVH) (HYDROXYCHLOROQUINE - UNII:4QWG6N8QKH) HYDROXYCHLOROQUINE SULFATE200 mg
Inactive Ingredients
Ingredient NameStrength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVAL (CAPSULE) Size13mm
FlavorImprint Code ZC38
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-633-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2008
2NDC:65841-633-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2008
3NDC:65841-633-3010 in 1 CARTON01/03/2008
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04065701/03/2008
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-633) , MANUFACTURE(65841-633)

Revised: 4/2020
Document Id: 9fd2c959-400a-4db7-9cb1-0f8741ad125d
Set id: 1aa44bff-9a62-48b4-a520-98d7d524e3a9
Version: 5
Effective Time: 20200421
 
Cadila Healthcare Limited