OLMESARTAN MEDOXOMIL - olmesartan medoxomil tablet, film coated 
Zydus Lifesciences Limited

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OLMESARTAN MEDOXOMIL TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1059-1

Olmesartan Medoxomil Tablets, 5 mg

Rx only

100 TABLETS

structured formula of olmesartan-image03

NDC 70771-1060-1

Olmesartan Medoxomil Tablets, 20 mg

Rx only

100 TABLETS

structured formula of olmesartan-image04

NDC 70771-1061-1

Olmesartan Medoxomil Tablets, 40 mg

Rx only

100 TABLETS

structured formula of olmesartan-image05
OLMESARTAN MEDOXOMIL 
olmesartan medoxomil tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1059
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10) OLMESARTAN MEDOXOMIL5 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size9mm
FlavorImprint Code 643
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1059-330 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2017
2NDC:70771-1059-990 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2017
3NDC:70771-1059-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2017
4NDC:70771-1059-5500 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2017
5NDC:70771-1059-01000 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2017
6NDC:70771-1059-710 in 1 CARTON04/24/2017
6NDC:70771-1059-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20519204/24/2017
OLMESARTAN MEDOXOMIL 
olmesartan medoxomil tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1060
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10) OLMESARTAN MEDOXOMIL20 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size9mm
FlavorImprint Code 644
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1060-330 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2017
2NDC:70771-1060-990 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2017
3NDC:70771-1060-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2017
4NDC:70771-1060-5500 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2017
5NDC:70771-1060-01000 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2017
6NDC:70771-1060-710 in 1 CARTON04/24/2017
6NDC:70771-1060-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20519204/24/2017
OLMESARTAN MEDOXOMIL 
olmesartan medoxomil tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1061
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10) OLMESARTAN MEDOXOMIL40 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVAL (OVAL) Size15mm
FlavorImprint Code 645
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1061-330 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2017
2NDC:70771-1061-990 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2017
3NDC:70771-1061-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2017
4NDC:70771-1061-5500 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2017
5NDC:70771-1061-01000 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2017
6NDC:70771-1061-710 in 1 CARTON04/24/2017
6NDC:70771-1061-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20519204/24/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (863362789)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1059, 70771-1060, 70771-1061) , MANUFACTURE(70771-1059, 70771-1060, 70771-1061)

Revised: 10/2022
Document Id: cfde6a89-090d-4b63-a11f-79c4919da819
Set id: 18f90bd4-cca2-4e70-845a-7021b818307e
Version: 4
Effective Time: 20221013
 
Zydus Lifesciences Limited