CHLORTHALIDONE - chlorthalidone tablet 
Zydus Lifesciences Limited

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Chlorthalidone Tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1369-1

Chlorthalidone tablets USP ,25 mg

Rx only

100 tablets

Chlorthalidone tablets, USP

NDC 70771-1370-1

Chlorthalidone tablets USP, 50 mg

Rx only

100 tablets

Chlorthalidone tablets, USP
CHLORTHALIDONE 
chlorthalidone tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1369
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORTHALIDONE (UNII: Q0MQD1073Q) (CHLORTHALIDONE - UNII:Q0MQD1073Q) CHLORTHALIDONE25 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorYELLOW (LIGHT YELLOW) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code Z25
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1369-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/15/2019
2NDC:70771-1369-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20781305/15/2019
CHLORTHALIDONE 
chlorthalidone tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1370
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORTHALIDONE (UNII: Q0MQD1073Q) (CHLORTHALIDONE - UNII:Q0MQD1073Q) CHLORTHALIDONE50 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITE (WHITE) Score2 pieces
ShapeROUND (ROUND) Size7mm
FlavorImprint Code Z;50
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1370-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/15/2019
2NDC:70771-1370-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20781305/15/2019
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1369, 70771-1370) , MANUFACTURE(70771-1369, 70771-1370)

Revised: 8/2022
Document Id: bc699058-b43d-4b7a-87f4-7933e55f2322
Set id: 6b432c76-b171-4c29-abf4-6d357976e6ef
Version: 3
Effective Time: 20220804
 
Zydus Lifesciences Limited