Amlodipine and Olmesartan Medoxomil

AMLODIPINE AND OLMESARTAN MEDOXOMIL- amlodipine besylate and olmesartan medoxomil tablet, film coated
Cadila Healthcare Limited

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
(click image for full-size original)

NDC 70771-1187-3

Amlodipine and olmesartan medoxomil tablets, 10/20 mg

Rx only

30 tablets

Amlodipine and olmesartan medoxomil  tablets
(click image for full-size original)

NDC 70771-1188-3

Amlodipine and olmesartan medoxomil tablets, 5/40 mg

Rx only

30 tablets

Amlodipine and olmesartan medoxomil  tablets
(click image for full-size original)

NDC 70771-1189-3

Amlodipine and olmesartan medoxomil tablets, 10/40 mg

Rx only

30 tablets

Amlodipine and olmesartan medoxomil  tablets
(click image for full-size original)
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine and olmesartan medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1186
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (WHITE) Score no score
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code 927
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1186-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1186-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1186-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1186-5 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1186-0 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207771 01/04/2018
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine and olmesartan medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1187
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE (ORANGE) Score no score
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code 928
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1187-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1187-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1187-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1187-5 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1187-0 1000 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:70771-1187-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1187-2)
6 NDC:70771-1187-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1187-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207771 01/04/2018
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine and olmesartan medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1188
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (PALE YELLOW) Score no score
Shape ROUND (ROUND) Size 9mm
Flavor Imprint Code 929
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1188-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1188-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1188-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1188-5 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1188-0 1000 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:70771-1188-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1188-2)
6 NDC:70771-1188-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1188-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207771 01/04/2018
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine and olmesartan medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1189
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE (ORANGE) Score no score
Shape ROUND (ROUND) Size 9mm
Flavor Imprint Code 930
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1189-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1189-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1189-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1189-5 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1189-0 1000 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:70771-1189-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1189-2)
6 NDC:70771-1189-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1189-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207771 01/04/2018
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 863362789 ANALYSIS (70771-1186), ANALYSIS (70771-1187), ANALYSIS (70771-1188), ANALYSIS (70771-1189), MANUFACTURE (70771-1186), MANUFACTURE (70771-1187), MANUFACTURE (70771-1188), MANUFACTURE (70771-1189)

Revised: 08/2020 Cadila Healthcare Limited

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