NDC Code(s) : 68084-258-11, 68084-258-01, 68084-259-11, 68084-259-01, 68084-260-11, 68084-260-01
Packager : American Health Packaging

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amlodipine BesylateAmlodipine Besylate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-258(NDC:31722-237)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE2.5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color white Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code 237;IG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68084-258-01100 in 1 BOX, UNIT-DOSE 17/01/2014
1NDC:68084-258-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077955 01/15/2014 01/31/2018
Amlodipine BesylateAmlodipine Besylate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-259(NDC:31722-238)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color white Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code 238;IG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68084-259-01100 in 1 BOX, UNIT-DOSE 23/01/2014
1NDC:68084-259-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077955 01/15/2014 04/30/2018
Amlodipine BesylateAmlodipine Besylate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-260(NDC:31722-239)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color white Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code 239;IG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68084-260-01100 in 1 BOX, UNIT-DOSE 23/01/2014
1NDC:68084-260-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077955 01/15/2014 12/31/2017

PRINCIPAL DISPLAY PANEL

2.5 mg Amlodipine Besylate Tablets Carton

NDC 68084-258-01

Amlodipine Besylate
Tablets, USP

2.5 mg*

100 Tablets (10 x 10)

*Each tablet contains amlodipine besylate, USP
equivalent to 2.5 mg amlodipine.

DOSAGE AND USE: See accompanying prescribing
information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
PROTECT FROM LIGHT.

Keep this and all drugs out of reach of children.

Rx Only

The drug product contained in this package is from
NDC # 31722-237, Camber Pharmaceutical, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

025801
Rv. 08/2013

PRINCIPAL DISPLAY PANEL

2.5 mg Amlodipine Besylate Tablet Blister

Amlodipine
Besylate
Tablet, USP

2.5 mg

PRINCIPAL DISPLAY PANEL

5 mg Amlodipine Besylate Tablets Carton

NDC 68084-259-01

Amlodipine Besylate
Tablets, USP

5 mg*

100 Tablets (10 x 10)

*Each tablet contains amlodipine besylate, USP
equivalent to 5 mg amlodipine.

DOSAGE AND USE: See accompanying prescribing
information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
PROTECT FROM LIGHT.

Keep this and all drugs out of reach of children.

Rx Only

The drug product contained in this package is from
NDC # 31722-238, Camber Pharmaceutical, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

025901
Rv. 08/2013

PRINCIPAL DISPLAY PANEL

5 mg Amlodipine Besylate Tablet Blister

Amlodipine
Besylate
Tablet, USP

5 mg

PRINCIPAL DISPLAY PANEL

10 mg Amlodipine Besylate Tablets Carton

NDC 68084-260-01

Amlodipine Besylate
Tablets, USP

10 mg*

100 Tablets (10 x 10)

*Each tablet contains amlodipine besylate, USP
equivalent to 10 mg amlodipine.

DOSAGE AND USE: See accompanying prescribing
information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
PROTECT FROM LIGHT.

Keep this and all drugs out of reach of children.

Rx Only

The drug product contained in this package is from
NDC # 31722-239, Camber Pharmaceutical, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

026001
Rv. 08/2013

PRINCIPAL DISPLAY PANEL

10 mg Amlodipine Besylate Tablet Blister

Amlodipine
Besylate
Tablets, USP

10 mg