LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- losartan potassium and hydrochlorothiazide tablet, film coated 
Cadila Healthcare Limited

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LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-732-06

Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg

30 Tablets

Rx Only

losahctz3

NDC 65841-733-06

Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg

30 Tablets

Rx Only

losahctz4
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 
losartan potassium and hydrochlorothiazide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-732
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg
LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89) LOSARTAN POTASSIUM50 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorWHITE (WHITE TO OFF WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size12mm
FlavorImprint Code ZD18
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-732-405000 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2010
2NDC:65841-732-0630 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2010
3NDC:65841-732-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2010
4NDC:65841-732-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07838504/10/2010
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 
losartan potassium and hydrochlorothiazide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-733
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE25 mg
LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89) LOSARTAN POTASSIUM100 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size13mm
FlavorImprint Code ZD19
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-733-0630 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2010
2NDC:65841-733-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2010
3NDC:65841-733-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2010
4NDC:65841-733-234000 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07838504/10/2010
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-732, 65841-733) , MANUFACTURE(65841-732, 65841-733)

Revised: 8/2020
Document Id: 38005e8c-d961-45db-ab79-7eab1d10780e
Set id: 6b098fd2-b0ee-42f9-97bc-837768dc4788
Version: 8
Effective Time: 20200831
 
Cadila Healthcare Limited