Prescription Drug Information: Amlodipine Besylate (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 2.5 mg — 90 Tablets Bottle

Package Label — Principal Display Panel — 2.5 mg — 90 Tablets

NDC 43489-102-01 *Rx only*
Amlodipine BesylateTablets, USP
2.5 mg* 90 Tablets

*Each tablet
contains amlodipine besylate, USP
equivalent to 2.5 mg amlodipine.
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].
PROTECT FROM LIGHT.

Dispense in a tight, light-resistant container [see USP].
Usual Dosage: See package Insert.
Manufactured by:
China Resources Saike Pharmaceutical Co., Ltd.
No. 3, Jinghai 7th Street, Tongzhou District, Beijing, 101111, China

Manufactured for:
Secan Pharmaceuticals, Inc.
81 Lancaster Ave. #210, Great Valley Center
Malvern, Pennsylvania 19355 Rev.: 07/17

2.5mg package
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 mg — 90 Tablets Bottle

Package Label — Principal Display Panel — 5 mg — 90 Tablets

NDC 43489-100-01 *Rx only*
Amlodipine BesylateTablets, USP
5 mg* 90 Tablets

*Each tablet
contains amlodipine besylate, USP
equivalent to 5 mg amlodipine.
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].
PROTECT FROM LIGHT.
Dispense in a tight, light-resistant container [see USP].
Usual Dosage: See package Insert.
Manufactured by:
China Resources Saike Pharmaceutical Co., Ltd.

No.3, Jinghai 7th Street, Tongzhou District, Beijing, 101111, China
Manufactured for:
Secan Pharmaceuticals, Inc.
81 Lancaster Ave. #210, Great Valley Center
Malvern, Pennsylvania 19355 Rev.: 07/17

5mg packaging
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg — 90 Tablets Bottle

Package Label — Principal Display Panel — 10 mg — 90 Tablets

NDC 43489-101-01 *Rx only*
Amlodipine BesylateTablets, USP 10 mg* 90 Tablets

*Each tablet

contains amlodipine besylate, USP
equivalent to 10 mg amlodipine.
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].
PROTECT FROM LIGHT.
Dispense in a tight, light-resistant container [see USP].
Usual Dosage: See package Insert.
Manufactured by:
China Resources Saike Pharmaceutical Co., Ltd.

NO.3, Jinghai 7th Street, Tongzhou District, Beijing, 101111, China
Manufactured for:
Secan Pharmaceuticals, Inc.
81 Lancaster Ave. #210, Great Valley Center
Malvern, Pennsylvania 19355 Rev.:07/17

10mg packaging
(click image for full-size original)
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43489-100
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color white Score no score
Shape OCTAGON (8 sided) Size 8mm
Flavor Imprint Code 5;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43489-100-01 90 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:43489-100-03 500 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:43489-100-05 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090752 04/15/2011
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43489-101
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color white Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 10;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43489-101-01 90 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:43489-101-03 500 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:43489-101-05 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090752 05/16/2016
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43489-102
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color white Score no score
Shape HEXAGON (6 sided) Size 5mm
Flavor Imprint Code 2;5;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43489-102-01 90 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:43489-102-10 300 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090752 04/15/2011
Labeler — China Resources Saike Pharmaceutical Co., Ltd. (653924605)

Revised: 09/2019 China Resources Saike Pharmaceutical Co., Ltd.

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