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

NDC 70771-1187-3

Amlodipine and olmesartan medoxomil tablets, 10/20 mg

Rx only

30 tablets

NDC 70771-1188-3

Amlodipine and olmesartan medoxomil tablets, 5/40 mg

Rx only

30 tablets

NDC 70771-1189-3

Amlodipine and olmesartan medoxomil tablets, 10/40 mg

Rx only

30 tablets

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