Amlodipine and Olmesartan Medoxomil (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Amlodipine and Olmesartan Medoxomil Tablets USP, 5 mg/20 mg are white colored, round shaped, biconvex, film-coated tablets, debossed with ‘K’ on one side and ‘27’ on the other side.

Bottles of 30 NDC 65862-854-30

Amlodipine and Olmesartan Medoxomil Tablets USP, 5 mg/40 mg are cream colored, round shaped, biconvex, film-coated tablets, debossed with ‘K’ on one side and ‘28’ on the other side.

Bottles of 30 NDC 65862-855-30

Amlodipine and Olmesartan Medoxomil Tablets USP, 10 mg/20 mg are peach colored, round shaped, biconvex, film-coated tablets, debossed with ‘K’ on one side and ‘29’ on the other side.

Bottles of 30 NDC 65862-856-30

Amlodipine and Olmesartan Medoxomil Tablets USP, 10 mg/40 mg are white colored, round shaped, biconvex, film-coated tablets, debossed with ‘K’ on one side and ‘30’ on the other side.

Bottles of 30 NDC 65862-857-30
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Pregnancy: Advise female patients of childbearing age about the consequences of exposure to amlodipine and olmesartan medoxomil during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

Lactation : Advise nursing women not to breastfeed during treatment with amlodipine and olmesartan medoxomil [see Use in Specific Populations (8.2)].

Potassium Supplements : Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider.

Maalox^® is a registered trademark of Novartis Consumer Health, Inc.

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India
Revised: 11/2022

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg/20 mg (30 Tablet Bottle)

NDC 65862-854-30
Rx only
Amlodipine and
Olmesartan Medoxomil
Tablets, USP
5 mg/20 mg
AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg/40 mg (30 Tablet Bottle)

NDC 65862-855-30
Rx only
Amlodipine and
Olmesartan Medoxomil
Tablets, USP
5 mg/40 mg
AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg/20 mg (30 Tablet Bottle)

NDC 65862-856-30
Rx only
Amlodipine and
Olmesartan Medoxomil
Tablets, USP
10 mg/20 mg
AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg/40 mg (30 Tablet Bottle)

NDC 65862-857-30
Rx only
Amlodipine and
Olmesartan Medoxomil
Tablets, USP
10 mg/40 mg
AUROBINDO 30 Tablets

AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-854 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 SILICON DIOXIDE CROSCARMELLOSE SODIUM POLYETHYLENE GLYCOL 3350 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYVINYL ALCOHOL, UNSPECIFIED STARCH, CORN TALC TITANIUM DIOXIDE

Product Characteristics Color WHITE Score no score Shape ROUND (Biconvex) Size 6mm Flavor Imprint Code K;27 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65862-854-30 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206906 05/15/2017

AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-855 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 SILICON DIOXIDE CROSCARMELLOSE SODIUM POLYETHYLENE GLYCOL 3350 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYVINYL ALCOHOL, UNSPECIFIED STARCH, CORN TALC TITANIUM DIOXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW

Product Characteristics Color WHITE (Cream) Score no score Shape ROUND (Biconvex) Size 8mm Flavor Imprint Code K;28 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65862-855-30 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206906 05/15/2017

AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-856 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 SILICON DIOXIDE CROSCARMELLOSE SODIUM POLYETHYLENE GLYCOL 3350 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYVINYL ALCOHOL, UNSPECIFIED STARCH, CORN TALC TITANIUM DIOXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW

Product Characteristics Color ORANGE (Peach) Score no score Shape ROUND (Biconvex) Size 8mm Flavor Imprint Code K;29 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65862-856-30 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206906 05/15/2017

AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-857 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 SILICON DIOXIDE CROSCARMELLOSE SODIUM POLYETHYLENE GLYCOL 3350 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYVINYL ALCOHOL, UNSPECIFIED STARCH, CORN TALC TITANIUM DIOXIDE

Product Characteristics Color WHITE Score no score Shape ROUND (Biconvex) Size 8mm Flavor Imprint Code K;30 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65862-857-30 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206906 05/15/2017

Labeler — Aurobindo Pharma Limited (650082092)

Establishment
Name	Address	ID/FEI	Operations
Aurobindo Pharma Limited		650381903	ANALYSIS (65862-854), ANALYSIS (65862-855), ANALYSIS (65862-856), ANALYSIS (65862-857), MANUFACTURE (65862-854), MANUFACTURE (65862-855), MANUFACTURE (65862-856), MANUFACTURE (65862-857)

Revised: 12/2022 Aurobindo Pharma Limited