Amlodipine Besylate and Olmesartran Medoxomil (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Amlodipine and Olmesartan Medoxomil Tablets are supplied as follows:

5 mg/20 mg: White round shape, film-coated debossed with ‘454’ on one side and plain on other side.

Bottles of 30 NDC# 46708-212-30

Bottles of 90 NDC# 46708-212-90

Bottles of 1000 NDC# 46708-212-91

5 mg/40 mg: Cream round shape, film-coated tablets debossed with ‘456’ on one side and plain on other side.

Bottles of 30 NDC# 46708-213-30

Bottles of 90 NDC# 46708-213-90

Bottles of 1000 NDC# 46708-213-91

10 mg/20 mg: Grayish orange round shape, film-coated tablets debossed with ‘455’ on one side and plain on other side.

Bottles of 30 NDC# 46708-214-30

Bottles of 90 NDC# 46708-214-90

Bottles of 1000 NDC# 46708-214-91

10 mg/40 mg: Brownish red round shape, film-coated tablets debossed with ‘457’ on one side and plain on the other side.

Bottles of 30 NDC# 46708-215-30

Bottles of 90 NDC# 46708-215-90

Bottles of 1000 NDC# 46708-215-91

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Pregnancy: Tell female patients of childbearing age about the consequences of exposure to amlodipine and olmesartan medoxomil tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by

Alembic Pharmaceuticals Limited (Formulation Division),

Village Panelav, P. O. Tajpura, Near Baska,

Taluka-Halol, Panchmahal, Gujarat, India.

Other brands mentioned are trademarks of their respective owners. The makers of these brands are not affiliated with Alembic Pharmaceuticals Limited or its products.

Revised: 06/2017

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5 mg/20 mg

Amlodipine and Olmesartan Medoxomil Tablets 5mg/20 mg (30 Tablets in 1 HDPE Bottle)
Each tablets contains 6.9 mg of amlodipine besylate USP equivalent to 5 mg amlodipine and 20 mg of olmesartan medoxomil USP. 46780-212-30

30's bottle pack
(click image for full-size original)

30’s bottle pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5 mg/40 mg

Amlodipine and Olmesartan Medoxomil Tablets 5mg/40 mg (30 Tablets in 1 HDPE Bottle)
Each tablets contains 6.9 mg of amlodipine besylate USP equivalent to 5 mg amlodipine and 40 mg of olmesartan medoxomil USP. 46708-213-30

30's bottle pack
(click image for full-size original)

30’s bottle pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 10 mg/20 mg

Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg (30 Tablets in 1 HDPE Bottle)
Each tablets contains 13.9 mg of amlodipine besylate USP equivalent to 10 mg amlodipine and 20 mg of olmesartan medoxomil USP. 46708-214-30

30's bottle pack
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 10 mg/40 mg

Amlodipine and Olmesartan Medoxomil Tablets 10 mg/40 mg (30 Tablets in 1 HDPE Bottle)
Each tablets contains 13.9 mg of amlodipine besylate USP equivalent to 10 mg amlodipine and 40 mg of olmesartan medoxomil USP. 46708-215-30

30's bottle pack
(click image for full-size original)
AMLODIPINE BESYLATE AND OLMESARTRAN MEDOXOMIL amlodipine besylate and olmesartran medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-212
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
CELLULOSE, MICROCRYSTALLINE
STARCH, POTATO
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3350
TALC
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 454
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-212-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-212-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:46708-212-91 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207073 07/18/2017
AMLODIPINE BESYLATE AND OLMESARTRAN MEDOXOMIL amlodipine besylate and olmesartran medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-213
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
CELLULOSE, MICROCRYSTALLINE
STARCH, POTATO
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3350
TALC
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
Product Characteristics
Color YELLOW (cream color) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 456
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-213-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-213-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:46708-213-91 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207073 07/18/2017
AMLODIPINE BESYLATE AND OLMESARTRAN MEDOXOMIL amlodipine besylate and olmesartran medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-214
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
CELLULOSE, MICROCRYSTALLINE
STARCH, POTATO
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3350
TALC
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
Product Characteristics
Color GRAY (grayish orange) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 455
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-214-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-214-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:46708-214-91 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207073 07/18/2017
AMLODIPINE BESYLATE AND OLMESARTRAN MEDOXOMIL amlodipine besylate and olmesartran medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-215
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
CELLULOSE, MICROCRYSTALLINE
STARCH, POTATO
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3350
TALC
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
Product Characteristics
Color BROWN (brownish red) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 457
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-215-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-215-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:46708-215-91 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207073 07/18/2017
Labeler — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (46708-212), MANUFACTURE (46708-213), MANUFACTURE (46708-214), MANUFACTURE (46708-215)

Revised: 09/2019 Alembic Pharmaceuticals Limited

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