AMLODIPINE AND OLMESARTAN MEDOXOMIL - amlodipine and olmesartan medoxomil tablet, film coated 
Zydus Lifesciences Limited

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AMLODIPINE and OLMESARTAN MEDOXOMIL Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1186-3

Amlodipine and olmesartan medoxomil tablets, 5/20 mg

Rx only

30 tablets

Amlodipine and olmesartan medoxomil tablets

NDC 70771-1187-3

Amlodipine and olmesartan medoxomil tablets, 10/20 mg

Rx only

30 tablets

Amlodipine and olmesartan medoxomil tablets

NDC 70771-1188-3

Amlodipine and olmesartan medoxomil tablets, 5/40 mg

Rx only

30 tablets

Amlodipine and olmesartan medoxomil tablets

NDC 70771-1189-3

Amlodipine and olmesartan medoxomil tablets, 10/40 mg

Rx only

30 tablets

Amlodipine and olmesartan medoxomil tablets
AMLODIPINE AND OLMESARTAN MEDOXOMIL 
amlodipine and olmesartan medoxomil tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1186
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE5 mg
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10) OLMESARTAN MEDOXOMIL20 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code 927
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1186-330 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
2NDC:70771-1186-990 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
3NDC:70771-1186-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
4NDC:70771-1186-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
5NDC:70771-1186-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20777101/04/2018
AMLODIPINE AND OLMESARTAN MEDOXOMIL 
amlodipine and olmesartan medoxomil tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1187
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE10 mg
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10) OLMESARTAN MEDOXOMIL20 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGE (ORANGE) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code 928
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1187-330 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
2NDC:70771-1187-990 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
3NDC:70771-1187-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
4NDC:70771-1187-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
5NDC:70771-1187-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
6NDC:70771-1187-410 in 1 CARTON01/04/2018
6NDC:70771-1187-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20777101/04/2018
AMLODIPINE AND OLMESARTAN MEDOXOMIL 
amlodipine and olmesartan medoxomil tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1188
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE5 mg
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10) OLMESARTAN MEDOXOMIL40 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOW (PALE YELLOW) Scoreno score
ShapeROUND (ROUND) Size9mm
FlavorImprint Code 929
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1188-330 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
2NDC:70771-1188-990 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
3NDC:70771-1188-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
4NDC:70771-1188-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
5NDC:70771-1188-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
6NDC:70771-1188-410 in 1 CARTON01/04/2018
6NDC:70771-1188-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20777101/04/2018
AMLODIPINE AND OLMESARTAN MEDOXOMIL 
amlodipine and olmesartan medoxomil tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1189
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE10 mg
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10) OLMESARTAN MEDOXOMIL40 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGE (ORANGE) Scoreno score
ShapeROUND (ROUND) Size9mm
FlavorImprint Code 930
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1189-330 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
2NDC:70771-1189-990 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
3NDC:70771-1189-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
4NDC:70771-1189-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
5NDC:70771-1189-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
6NDC:70771-1189-410 in 1 CARTON01/04/2018
6NDC:70771-1189-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20777101/04/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1186, 70771-1187, 70771-1188, 70771-1189) , MANUFACTURE(70771-1186, 70771-1187, 70771-1188, 70771-1189)

Revised: 10/2022
Document Id: adc1edc9-9897-4ba0-a14d-08c8d29f9369
Set id: 7fe70118-ec04-40c6-8582-04ad416c2fe2
Version: 4
Effective Time: 20221013
 
Zydus Lifesciences Limited