LOSARTAN POTASSIUM- losartan potassium tablet, film coated 
Cadila Healthcare Limited

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LOSARTAN POTASSIUM TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-729-01

Losartan Potassium Tablets USP, 25 mg

Rx Only

100 Tablets

Zydus

losapotatabA

NDC 65841-730-01

Losartan Potassium Tablets USP, 50 mg

Rx Only

100 Tablets

Zydus

losapotatabB

NDC 65841-731-01

Losartan Potassium Tablets USP, 100 mg

Rx Only

100 Tablets

Zydus

losapotatabC
LOSARTAN POTASSIUM 
losartan potassium tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-729
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89) LOSARTAN POTASSIUM25 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) Size8mm
FlavorImprint Code Z;2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-729-0630 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
2NDC:65841-729-1690 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
3NDC:65841-729-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
4NDC:65841-729-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
5NDC:65841-729-2410000 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07824310/04/2010
LOSARTAN POTASSIUM 
losartan potassium tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-730
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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) Score2 pieces
ShapeCAPSULE (CAPSULE) Size11mm
FlavorImprint Code Z16
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-730-0630 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
2NDC:65841-730-1690 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
3NDC:65841-730-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
4NDC:65841-730-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
5NDC:65841-730-2410000 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07824310/04/2010
LOSARTAN POTASSIUM 
losartan potassium tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-731
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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) Size12mm
FlavorImprint Code Z18
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-731-0630 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
2NDC:65841-731-1690 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
3NDC:65841-731-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
4NDC:65841-731-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
5NDC:65841-731-7710 in 1 CARTON10/04/2010
5NDC:65841-731-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07824310/04/2010
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
CADILA HEALTHCARE LIMITED677605858ANALYSIS(65841-729, 65841-730, 65841-731) , MANUFACTURE(65841-729, 65841-730, 65841-731)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-729, 65841-730, 65841-731) , MANUFACTURE(65841-729, 65841-730, 65841-731)

Revised: 9/2020
Document Id: 065e4ccc-1899-4d12-b996-7e45e7ec638b
Set id: 9ccd6823-e813-472c-99cd-c6ef25e74bed
Version: 9
Effective Time: 20200901
 
Cadila Healthcare Limited