Amlodipine and Olmesartan Medoxomil (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Amlodipine and olmesartan medoxomil tablets contain amlodipine besylate at a dose equivalent to 5 or 10 mg amlodipine and olmesartan medoxomil in the strengths described below.

Amlodipine and olmesartan medoxomil tablets are differentiated by tablet color/size and are debossed with an individual product tablet code on one side. Amlodipine and olmesartan medoxomil tablets are supplied for oral administration in the following strength and package configurations:

Reduction in Seated Systolic/Diastolic Blood Pressure (mmHg): Combination Therapy vs. Monotherapy Components (Double-Blind Treatment Period)

Tablet Strength (amlodipine equivalent/ olmesartan medoxomil) mg	Package Configuration	NDC#	Product Code	Tablet Color
5/20 mg	Bottle of 30Bottle of 90Bottle of 1000	50228-365-3050228-365-9050228-365-10	SG 365	White
10/20 mg	Bottle of 30Bottle of 90 Bottle of 1000	50228-367-3050228-367-90 50228-367-10	SG 367	Light Orange
5/40 mg	Bottle of 30Bottle of 90 Bottle of 1000	50228-366-3050228-366-90 50228-366-10	SG 366	Cream
10/40 mg	Bottle of 30Bottle of 90 Bottle of 1000	50228-368-3050228-368-90 50228-368-10	SG 368	Brownish Red

Store at 25ºC (77ºF); excursions permitted to 15°C to 30ºC (59°F to 86ºF) [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.

Manufactured by:
ScieGen Pharmaceuticals, Inc.
Hauppauge, NY 11788

Rev. 02/17

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

NDC 50228-365-30

Amlodipine and

Olmesartan Medoxomil

Tablets

5 mg/20 mg

Each tablet contains 6.9 mg of amlodipine besylate

30 Tablets Rx Only

ScieGen Pharmaceuticals, Inc.

NDC 50228-365-90

Amlodipine and

Olmesartan Medoxomil

Tablets

5 mg/20 mg

Each tablet contains 6.9 mg of amlodipine besylate

90 Tablets Rx Only

ScieGen Pharmaceuticals, Inc.

NDC 50228-365-10

Amlodipine and

Olmesartan Medoxomil

Tablets

5 mg/20 mg

Each tablet contains 6.9 mg of amlodipine besylate

1,000 Tablets Rx Only

ScieGen Pharmaceuticals, Inc.

NDC 50228-366-30

Amlodipine and

Olmesartan Medoxomil

Tablets

5 mg/40 mg

Each tablet contains 6.9 mg of amlodipine besylate

30 Tablets Rx Only

ScieGen Pharmaceuticals, Inc.

NDC 50228-366-90

Amlodipine and

Olmesartan Medoxomil

Tablets

5 mg/40 mg

Each tablet contains 6.9 mg of amlodipine besylate

90 Tablets Rx Only

ScieGen Pharmaceuticals, Inc.

NDC 50228-366-10

Amlodipine and

Olmesartan Medoxomil

Tablets

5 mg/40 mg

Each tablet contains 6.9 mg of amlodipine besylate

1,000 Tablets Rx Only

ScieGen Pharmaceuticals, Inc.

NDC 50228-367-30

Amlodipine and

Olmesartan Medoxomil

Tablets

10 mg/20 mg

Each tablet contains 13.9 mg of amlodipine besylate

30 Tablets Rx Only

ScieGen Pharmaceuticals, Inc.

NDC 50228-367-90

Amlodipine and

Olmesartan Medoxomil

Tablets

10 mg/20 mg

Each tablet contains 13.9 mg of amlodipine besylate

90 Tablets Rx Only

ScieGen Pharmaceuticals, Inc.

NDC 50228-367-10

Amlodipine and

Olmesartan Medoxomil

Tablets

10 mg/20 mg

Each tablet contains 13.9 mg of amlodipine besylate

1,000 Tablets Rx Only

ScieGen Pharmaceuticals, Inc.

NDC 50228-368-30

Amlodipine and

Olmesartan Medoxomil

Tablets

10 mg/40 mg

Each tablet contains 13.9 mg of amlodipine besylate

30 Tablets Rx Only

ScieGen Pharmaceuticals, Inc.

NDC 50228-368-90

Amlodipine and

Olmesartan Medoxomil

Tablets

10 mg/40 mg

Each tablet contains 13.9 mg of amlodipine besylate

90 Tablets Rx Only

ScieGen Pharmaceuticals, Inc.

NDC 50228-368-10

Amlodipine and

Olmesartan Medoxomil

Tablets

10 mg/40 mg

Each tablet contains 13.9 mg of amlodipine besylate

1,000 Tablets Rx Only

ScieGen Pharmaceuticals, Inc.

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

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-365 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 MICROCRYSTALLINE CELLULOSE STARCH, CORN CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE POLYVINYL ALCOHOL, UNSPECIFIED POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 8000 TITANIUM DIOXIDE TALC

Product Characteristics Color WHITE Score no score Shape ROUND (Biconvex) Size 7mm Flavor Imprint Code SG;365 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50228-365-30 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:50228-365-90 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:50228-365-10 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209010 12/03/2018

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

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-366 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 MICROCRYSTALLINE CELLULOSE STARCH, CORN CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE POLYVINYL ALCOHOL, UNSPECIFIED POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 8000 TITANIUM DIOXIDE TALC FERRIC OXIDE YELLOW

Product Characteristics Color yellow (light yellow) Score no score Shape ROUND (Biconvex) Size 8mm Flavor Imprint Code SG;366 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50228-366-30 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:50228-366-90 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:50228-366-10 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209010 12/03/2018

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

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-367 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 MICROCRYSTALLINE CELLULOSE STARCH, CORN CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE POLYVINYL ALCOHOL, UNSPECIFIED POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 8000 TITANIUM DIOXIDE TALC FERRIC OXIDE YELLOW FERRIC OXIDE RED

Product Characteristics Color ORANGE (Light Orange) Score no score Shape ROUND (Biconvex) Size 7mm Flavor Imprint Code SG;367 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50228-367-30 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:50228-367-90 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:50228-367-10 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209010 12/03/2018

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

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-368 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 MICROCRYSTALLINE CELLULOSE STARCH, CORN CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE POLYVINYL ALCOHOL, UNSPECIFIED POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 8000 TITANIUM DIOXIDE TALC FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE

Product Characteristics Color red (Brownish Red) Score no score Shape ROUND (Biconvex) Size 8mm Flavor Imprint Code SG;368 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50228-368-30 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:50228-368-90 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:50228-368-10 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209010 12/03/2018

Labeler — ScieGen Pharmaceuticals, Inc (079391286)

Establishment
Name	Address	ID/FEI	Operations
ScieGen Pharmaceuticals, Inc		079391286	ANALYSIS (50228-365), ANALYSIS (50228-366), ANALYSIS (50228-367), ANALYSIS (50228-368), MANUFACTURE (50228-365), MANUFACTURE (50228-366), MANUFACTURE (50228-367), MANUFACTURE (50228-368)

Revised: 12/2018 ScieGen Pharmaceuticals, Inc